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HQ SPCLT PHARMA
FDA Orange Book

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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Jai Radhe Sales is your partner for all your sourcing needs.

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xyz-pharma-m-2024-10-07

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Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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xyz-pharma-m-2024-10-07

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HQ SPCLT PHARMA

Contact Details

CONTACT DETAILS
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EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

DIGITAL CONTENT

INTERVIEW #SpeakPharma, VLOG #PharmaReel, DATA COMPILATION #PharmaFlow, 5 NEWS #PharmaBuzz

INTERVIEW #SpeakPharma
VLOG #PharmaReel
DATA COMPILATION #PharmaFlow
5 NEWS #PharmaBuzz

FINISHED DOSAGE FORMULATIONS

33 FDF Dossiers, 33 FDA Orange Book

33 FDF Dossiers
33 FDA Orange Book

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33 All

01 3CALCIUM GLUCONATE

02 1CEFAZOLIN SODIUM

03 1CILASTATIN SODIUM; IMIPENEM

04 4CISPLATIN

05 4DEXMEDETOMIDINE HYDROCHLORIDE

06 4ESMOLOL HYDROCHLORIDE

07 4LEVETIRACETAM

08 2LINEZOLID

09 6MAGNESIUM SULFATE

10 3MEROPENEM

11 1PACLITAXEL

filter Dosage Reset all filters

33 All

01 15INJECTABLE;INJECTION

02 4INJECTABLE;INTRAVENOUS

03 3POWDER;INTRAVENOUS

04 11SOLUTION;INTRAVENOUS

filter Dosage Strength Reset all filters

33 All

01 10.5MG/ML

02 11.5GM/100ML (15MG/ML)

03 110MG/VIAL

04 21GM/100ML

05 21GM/100ML (10MG/ML)

06 11GM/50ML (20MG/ML)

07 11GM/VIAL

08 11MG/ML

09 12.5GM/250ML (10MG/ML)

10 1200MG/100ML (2MG/ML)

11 120GM/500ML (40MG/ML)

12 1250MG/50ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

13 12GM/100ML

14 22GM/100ML (20MG/ML)

15 12GM/50ML (40MG/ML)

16 12GM/VIAL

17 140GM/1000ML (40MG/ML)

18 14GM/100ML (40MG/ML)

19 14GM/50ML (80MG/ML)

20 1500MG/100ML (5MG/ML)

21 1500MG/VIAL

22 150MG/VIAL

23 1600MG/300ML (2MG/ML)

24 16MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

25 1EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)

26 1EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)

27 1EQ 2GM BASE/VIAL

28 1EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)

29 1EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)

30 1EQ 500MG BASE/VIAL;500MG/VIAL

filter Regulatory Info Reset all filters

33 All

01 4DISCN

02 29RX

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01

Brand Name : CALCIUM GLUCONATE IN...

U.S.A

BioFlorida Conference

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Brand Name : CALCIUM GLUCONATE IN...

U.S.A

BioFlorida Conference

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RLD : Yes

TE Code :

CALCIUM GLUCONATE

HQ SPCLT PHARMA

Dosage Form : SOLUTION; INTRAVENOUS

Proprietary Name : CALCIUM GLUCONATE IN SOD...

Dosage Strength : 1GM/50ML (20MG/ML)

Approval Date : 2018-10-29

Application Number : 210906

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Product
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02

Brand Name : CALCIUM GLUCONATE IN...

U.S.A

BioFlorida Conference

Not Confirmed

Brand Name : CALCIUM GLUCONATE IN...

U.S.A

BioFlorida Conference

Not Confirmed

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U.S.A

Digital Content

RLD : Yes

TE Code :

CALCIUM GLUCONATE

HQ SPCLT PHARMA

Dosage Form : SOLUTION; INTRAVENOUS

Proprietary Name : CALCIUM GLUCONATE IN SOD...

Dosage Strength : 2GM/100ML (20MG/ML)

Approval Date : 2018-10-29

Application Number : 210906

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Product
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03

Brand Name : CALCIUM GLUCONATE IN...

U.S.A

BioFlorida Conference

Not Confirmed

Brand Name : CALCIUM GLUCONATE IN...

U.S.A

BioFlorida Conference

Not Confirmed

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RLD : Yes

TE Code :

CALCIUM GLUCONATE

HQ SPCLT PHARMA

Dosage Form : SOLUTION; INTRAVENOUS

Proprietary Name : CALCIUM GLUCONATE IN SOD...

Dosage Strength : 1GM/100ML (10MG/ML)

Approval Date : 2021-06-04

Application Number : 210906

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Product
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04

Brand Name : CEFAZOLIN SODIUM

U.S.A

BioFlorida Conference

Not Confirmed

Brand Name : CEFAZOLIN SODIUM

U.S.A

BioFlorida Conference

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RLD : Yes

TE Code :

CEFAZOLIN SODIUM

HQ SPCLT PHARMA

Dosage Form : POWDER; INTRAVENOUS

Proprietary Name : CEFAZOLIN SODIUM

Dosage Strength : EQ 2GM BASE/VIAL

Approval Date : 2023-05-08

Application Number : 211413

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Product
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05

Brand Name : IMIPENEM AND CILASTA...

U.S.A

BioFlorida Conference

Not Confirmed

Brand Name : IMIPENEM AND CILASTA...

U.S.A

BioFlorida Conference

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RLD : No

TE Code : AP

CILASTATIN SODIUM; IMIPENEM

HQ SPCLT PHARMA

Dosage Form : POWDER; INTRAVENOUS

Proprietary Name : IMIPENEM AND CILASTATIN

Dosage Strength : EQ 500MG BASE/VIAL;500MG...

Approval Date : 2019-12-12

Application Number : 207594

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

Product
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06

Brand Name : PLATINOL

U.S.A

BioFlorida Conference

Not Confirmed

Brand Name : PLATINOL

U.S.A

BioFlorida Conference

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RLD : Yes

TE Code :

HQ SPCLT PHARMA

Dosage Form : INJECTABLE; INJECTION

Proprietary Name : PLATINOL

Dosage Strength : 10MG/VIAL

Approval Date : 1982-01-01

Application Number : 18057

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Product
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07

Brand Name : CISPLATIN

U.S.A

BioFlorida Conference

Not Confirmed

Brand Name : CISPLATIN

U.S.A

BioFlorida Conference

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RLD : Yes

TE Code :

HQ SPCLT PHARMA

Dosage Form : INJECTABLE; INJECTION

Proprietary Name : CISPLATIN

Dosage Strength : 50MG/VIAL

Approval Date : 1982-01-01

Application Number : 18057

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Product
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08

Brand Name : PLATINOL-AQ

U.S.A

BioFlorida Conference

Not Confirmed

Brand Name : PLATINOL-AQ

U.S.A

BioFlorida Conference

Not Confirmed

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RLD : Yes

TE Code :

HQ SPCLT PHARMA

Dosage Form : INJECTABLE; INJECTION

Proprietary Name : PLATINOL-AQ

Dosage Strength : 0.5MG/ML

Approval Date : 1984-07-18

Application Number : 18057

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Product
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09

Brand Name : CISPLATIN

U.S.A

BioFlorida Conference

Not Confirmed

Brand Name : CISPLATIN

U.S.A

BioFlorida Conference

Not Confirmed

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RLD : Yes

TE Code : AP

HQ SPCLT PHARMA

Dosage Form : INJECTABLE; INJECTION

Proprietary Name : CISPLATIN

Dosage Strength : 1MG/ML

Approval Date : 1988-11-08

Application Number : 18057

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

Product
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10

Brand Name : DEXMEDETOMIDINE HYDR...

U.S.A

BioFlorida Conference

Not Confirmed

Brand Name : DEXMEDETOMIDINE HYDR...

U.S.A

BioFlorida Conference

Not Confirmed

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RLD : Yes

TE Code : AP

DEXMEDETOMIDINE HYDROCHLORIDE

HQ SPCLT PHARMA

Dosage Form : SOLUTION; INTRAVENOUS

Proprietary Name : DEXMEDETOMIDINE HYDROCHL...

Dosage Strength : EQ 400MCG BASE/4ML (EQ 1...

Approval Date : 2015-10-21

Application Number : 206628

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

Product
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