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26-28 November, 2024
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11-14 November, 2024
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11-13 November, 2024
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Events
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CPhI India 2024CPhI India 2024
Industry Trade Show
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26-28 November, 2024
Industry Trade Show
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11-14 November, 2024
The Pharmacy Technolog...The Pharmacy Technology
Industry Trade Show
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11-13 November, 2024
Digital content
INTERVIEW #SpeakPharma
[Sponsored by another company]https://www.pharmacompass.com/speak-pharma/lgm-pharma-has-made-significant-strides-in-meeting-the-evolving-needs-of-its-clients
VLOG #PharmaReel
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04 Jun 2024
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125545
23 May 2024
// Zoey Becker FIERCE PHARMA
https://www.fiercepharma.com/manufacturing/pfizers-hospira-recalls-five-lots-injectables-due-leaking-product-potential-seal
22 May 2024
// FDA
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hospira-inc-issues-voluntary-nationwide-recall-buprenorphine-hydrochloride-injection-carpujecttm
16 Feb 2024
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761080
27 Dec 2023
// Fraiser Kansteiner FIERCE PHARMA
https://www.fiercepharma.com/pharma/pfizers-hospira-recall-spree-bleeds-2024-product-pulls-multiple-hospital-drugs-shortage
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hospira-inc-issues-voluntary-nationwide-recall-42-sodium-bicarbonate-injection-84-sodium-bicarbonate
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15079
Submission : 2000-10-06
Status : Inactive
Type : II
Registration Number : 221MF10272
Registrant's Address : 4876 Sterling Drive Boulder, CO 80301, USA
Initial Date of Registration : 2009-12-09
Latest Date of Registration :
Registrant Name : Korea Pfizer Pharmaceutical Co., Ltd.
Registration Date : 2005-08-31
Registration Number : 20050831-68-A-132-02
Manufacturer Name : Corden Pharma Boulder, Inc.
Manufacturer Address : 4876 Sterling Drive, Boulder, Colorado (CO) 80301, USA
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16923
Submission : 2005-03-11
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25212
Submission : 2011-08-16
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24367
Submission : 2010-11-15
Status : Inactive
Type : II
Certificate Number : R1-CEP 2010-259 - Rev 00
Issue Date : 2016-12-20
Type : Chemical
Substance Number : 2017
Status : Withdrawn by Holder
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16439
Submission : 2003-02-19
Status : Active
Type : II
Registrant Name : Korea Pfizer Pharmaceutical Co., Ltd.
Registration Date : 2005-08-31
Registration Number : 20050831-68-A-132-02
Manufacturer Name : Corden Pharma Boulder, Inc.
Manufacturer Address : 4876 Sterling Drive, Boulder, Colorado (CO) 80301, USA
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registration Number : 227MF10224
Registrant's Address : 4876 Sterling Drive Boulder, CO 80301, USA
Initial Date of Registration : 2015-09-03
Latest Date of Registration :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13709
Submission : 1998-09-01
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11365
Submission : 1995-02-23
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13905
Submission : 1998-12-21
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10012
Submission : 1992-12-16
Status : Inactive
Type : II
Details:
Propofol is an intravenous general anesthetic and sedation drug for use in the induction and maintenance of anesthesia or sedation. Propofol Injectable Emulsion is a terminally sterilized (TS) product.
Lead Product(s): Propofol
Therapeutic Area: Neurology Brand Name: Propofol-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 22, 2022
Details : Propofol is an intravenous general anesthetic and sedation drug for use in the induction and maintenance of anesthesia or sedation. Propofol Injectable Emulsion is a terminally sterilized (TS) product.
Brand Name : Propofol-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 22, 2022
Details:
Propofol is an intravenous general anesthetic and sedation drug for use in the induction and maintenance of anesthesia or sedation. Propofol Injectable Emulsion, USP is a terminally sterilized (TS) product.
Lead Product(s): Propofol
Therapeutic Area: Neurology Brand Name: Propofol-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 13, 2022
Details : Propofol is an intravenous general anesthetic and sedation drug for use in the induction and maintenance of anesthesia or sedation. Propofol Injectable Emulsion, USP is a terminally sterilized (TS) product.
Brand Name : Propofol-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
July 13, 2022
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : INJECTABLE;INJECTION
Brand Name : ACETAZOLAMIDE SODIUM
Dosage Strength : EQ 500MG BASE/VIAL
Packaging :
Approval Date : 1995-10-30
Application Number : 40108
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info :
Registration Country : Italy
Acetyl-Lysyl-Prolyl-Seryl-Seryl-Prolyl-Prolyl-Glutamyl-Glutamic Acid Amide
Dosage Form : Urokinase 100.000Iu 2Ml ...
Brand Name : Urokinasi
Dosage Strength : 1 bottle 100,000 IU + ...
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : SOLUTION;INHALATION, ORA...
Brand Name : ACETYLCYSTEINE
Dosage Strength : 10%
Packaging :
Approval Date : 1989-05-01
Application Number : 71364
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : SOLUTION;INHALATION, ORA...
Brand Name : ACETYLCYSTEINE
Dosage Strength : 20%
Packaging :
Approval Date : 1994-08-30
Application Number : 74037
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : SOLUTION;INHALATION, ORA...
Brand Name : ACETYLCYSTEINE
Dosage Strength : 10%
Packaging :
Approval Date : 1994-08-30
Application Number : 73664
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : SOLUTION;INHALATION, ORA...
Brand Name : ACETYLCYSTEINE
Dosage Strength : 20%
Packaging :
Approval Date : 1989-05-01
Application Number : 71365
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info :
Registration Country : Norway
Dosage Form : Concentrate to the infus...
Brand Name : Aciclovir Hospira
Dosage Strength : 25 mg/ml
Packaging : Hood glass with plastic Sheaths
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Dosage Form : Concentrate to the infus...
Brand Name : Aciclovir Hospira
Dosage Strength : 25 mg/ml
Packaging : Hood glass with plastic Sheaths
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Dosage Form : Concentrate to the infus...
Brand Name : Aciclovir Hospira
Dosage Strength : 25 mg/ml
Packaging : Hood glass with plastic Sheaths
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : INJECTABLE;INJECTION
Brand Name : ACYCLOVIR SODIUM
Dosage Strength : EQ 50MG BASE/ML
Packaging :
Approval Date : 1999-02-25
Application Number : 75065
Regulatory Info : DISCN
Registration Country : USA
RLD : No
TE Code :
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : ACETAZOLAMIDE SODIUM
Dosage Strength : EQ 500MG BASE/VIAL
Approval Date : 1995-10-30
Application Number : 40108
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Dosage Form : SOLUTION; INHALATION, ORAL
Proprietary Name : ACETYLCYSTEINE
Dosage Strength : 10%
Approval Date : 1989-05-01
Application Number : 71364
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Dosage Form : SOLUTION; INHALATION, ORAL
Proprietary Name : ACETYLCYSTEINE
Dosage Strength : 20%
Approval Date : 1989-05-01
Application Number : 71365
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code : AN
Dosage Form : SOLUTION; INHALATION, ORAL
Proprietary Name : ACETYLCYSTEINE
Dosage Strength : 10%
Approval Date : 1994-08-30
Application Number : 73664
RX/OTC/DISCN : RX
RLD : No
TE Code : AN
RLD : No
TE Code : AN
Dosage Form : SOLUTION; INHALATION, ORAL
Proprietary Name : ACETYLCYSTEINE
Dosage Strength : 20%
Approval Date : 1994-08-30
Application Number : 74037
RX/OTC/DISCN : RX
RLD : No
TE Code : AN
RLD : No
TE Code :
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : ACYCLOVIR SODIUM
Dosage Strength : EQ 500MG BASE/VIAL
Approval Date : 1997-04-22
Application Number : 74663
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : ACYCLOVIR SODIUM
Dosage Strength : EQ 1GM BASE/VIAL
Approval Date : 1997-04-22
Application Number : 74663
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : ACYCLOVIR SODIUM
Dosage Strength : EQ 25MG BASE/ML
Approval Date : 1997-04-22
Application Number : 74720
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : ACYCLOVIR SODIUM
Dosage Strength : EQ 500MG BASE/VIAL
Approval Date : 1997-04-22
Application Number : 74758
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : ACYCLOVIR SODIUM
Dosage Strength : EQ 1GM BASE/VIAL
Approval Date : 1997-04-22
Application Number : 74758
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
Inspections and registrations
District Decision : No Action Indicated
Inspection End Date : 2016-07-14
City : Lake Forest
State : IL
Country/Area : US
Zip : 60045-2579
District : CHI
Center : CDRH
Project Area : Compliance: Devices
District Decision : No Action Indicated
Inspection End Date : 2016-07-14
District Decision : Official Action Indicated
Inspection End Date : 2015-05-27
City : Lake Forest
State : IL
Country/Area : US
Zip : 60045-2579
District : CHI
Center : CDRH
Project Area : Postmarket Assurance: Devices
District Decision : Official Action Indicated
Inspection End Date : 2015-05-27
District Decision : Official Action Indicated
Inspection End Date : 2015-05-27
City : Lake Forest
State : IL
Country/Area : US
Zip : 60045-2579
District : CHI
Center : CDRH
Project Area : Compliance: Devices
District Decision : Official Action Indicated
Inspection End Date : 2015-05-27
District Decision : No Action Indicated
Inspection End Date : 2014-05-28
City : Lake Forest
State : IL
Country/Area : US
Zip : 60045-2579
District : CHI
Center : CDRH
Project Area : Postmarket Assurance: Devices
District Decision : No Action Indicated
Inspection End Date : 2014-05-28
District Decision : Voluntary Action Indicated
Inspection End Date : 2014-05-28
City : Lake Forest
State : IL
Country/Area : US
Zip : 60045-2579
District : CHI
Center : CDRH
Project Area : Compliance: Devices
District Decision : Voluntary Action Indicated
Inspection End Date : 2014-05-28
District Decision : Official Action Indicated
Inspection End Date : 2013-02-07
City : Lake Forest
State : IL
Country/Area : US
Zip : 60045-2579
District : CHI
Center : CDRH
Project Area : Postmarket Assurance: Devices
District Decision : Official Action Indicated
Inspection End Date : 2013-02-07
District Decision : Official Action Indicated
Inspection End Date : 2013-02-07
City : Lake Forest
State : IL
Country/Area : US
Zip : 60045-2579
District : CHI
Center : CDRH
Project Area : Compliance: Devices
District Decision : Official Action Indicated
Inspection End Date : 2013-02-07
District Decision : Voluntary Action Indicated
Inspection End Date : 2012-07-13
City : Lake Forest
State : IL
Country/Area : US
Zip : 60045-2579
District : CHI
Center : CDRH
Project Area : Postmarket Assurance: Devices
District Decision : Voluntary Action Indicated
Inspection End Date : 2012-07-13
District Decision : Voluntary Action Indicated
Inspection End Date : 2012-07-13
City : Lake Forest
State : IL
Country/Area : US
Zip : 60045-2579
District : CHI
Center : CDRH
Project Area : Compliance: Devices
District Decision : Voluntary Action Indicated
Inspection End Date : 2012-07-13
District Decision : No Action Indicated
Inspection End Date : 2009-07-20
City : Lake Forest
State : IL
Country/Area : US
Zip : 60045-2579
District : CHI
Center : CDRH
Project Area : Compliance: Devices
District Decision : No Action Indicated
Inspection End Date : 2009-07-20
ABOUT THIS PAGE
HOSPIRA INC is a supplier offers 33 products (APIs, Excipients or Intermediates).
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