GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36506
Submission : 2022-06-16
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28449
Submission : 2014-06-16
Status : Active
Type : IV
Certificate Number : R1-CEP 2016-283 - Rev 01
Issue Date : 2023-01-12
Type : Chemical
Substance Number : 1444
Status : Valid
Certificate Number : R1-CEP 2009-392 - Rev 01
Issue Date : 2022-07-06
Type : Chemical
Substance Number : 1444
Status : Valid
Certificate Number : CEP 2006-085 - Rev 04
Issue Date : 2024-09-18
Type : Chemical
Substance Number : 1444
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36506
Submission : 2022-06-16
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28449
Submission : 2014-06-16
Status : Active
Type : IV
Certificate Number : R1-CEP 2016-283 - Rev 01
Status : Valid
Issue Date : 2023-01-12
Type : Chemical
Substance Number : 1444
Certificate Number : R1-CEP 2009-392 - Rev 01
Status : Valid
Issue Date : 2022-07-06
Type : Chemical
Substance Number : 1444
Macrogols, Types 3350 and 4000
Certificate Number : CEP 2006-085 - Rev 04
Status : Valid
Issue Date : 2024-09-18
Type : Chemical
Substance Number : 1444
NDC Package Code : 59044-0007
Start Marketing Date : 2006-03-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (22.7kg/22.7kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 59044-0027
Start Marketing Date : 2006-03-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (907kg/907kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 59044-0017
Start Marketing Date : 2018-06-21
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
FINISHED DOSAGE FORMULATIONS
Drug : CLARITHROMYCIN
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Application Number : 65154
Country : US
Patented : No
Drug : VALGANCICLOVIR HYDROCHLORIDE
Dosage Form : TABLET; ORAL
Application Number : 200790
Country : US
Patented : No
Drug : IBUPROFEN
Dosage Form : TABLET; ORAL
Application Number : 78329
Country : US
Patented : No
Drug : DONEPEZIL HYDROCHLORIDE
Dosage Form : TABLET; ORAL
Application Number : 202415
Country : US
Patented : No
Drug : ROSUVASTATIN CALCIUM
Dosage Form : TABLET; ORAL
Application Number : 79167
Country : US
Patented : No
HYDROCHLOROTHIAZIDE; VALSARTAN
Drug : VALSARTAN AND HYDROCHLOROTHIAZIDE
Dosage Form : TABLET; ORAL
Application Number : 91519
Country : US
Patented : No
Drug : RANOLAZINE
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Application Number : 209953
Country : US
Patented : No
Drug : LACOSAMIDE
Dosage Form : SOLUTION; ORAL
Application Number : 214672
Country : US
Patented : No
Drug : OMEPRAZOLE MAGNESIUM
Dosage Form : TABLET, DELAYED RELEASE; ORAL
Application Number : 206877
Country : US
Patented : No
AMOXICILLIN; CLAVULANATE POTASSIUM
Drug : AMOXICILLIN AND CLAVULANATE POTASSIUM
Dosage Form : TABLET; ORAL
Application Number : 91568
Country : US
Patented : No
EXCIPIENTS BY APPLICATIONS
Dosage Form : Cream / Lotion / Ointment
Grade : Oral, Topical & Parenteral
Category : Emulsifying Agents
Brand Name : PEG/Macrogol 4000
Application : Emulsifying Agents
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Polyethylene Glycol 4000
Application : Emulsifying Agents
Excipient Details : W/O Emulsifier
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : PEG 30 Dipolyhydroxystearate
Brand Name : PEG/Macrogol 4000
Application : Parenteral
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Polyethylene Glycol 4000
MARKET PLACE
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