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HQ SPCLT PHARMA
FDA Orange Book

Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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xyz-pharma-m-2025-03-24

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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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Gentec Pharmaceutical Group is focused on manufacturing & developing APIs/HPAPIs, Advanced Intermediates & Fine Chemicals.

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xyz-pharma-m-2025-03-17

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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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35 All

01 3CALCIUM GLUCONATE

02 1CEFAZOLIN SODIUM

03 1CILASTATIN SODIUM; IMIPENEM

04 4CISPLATIN

05 4DEXMEDETOMIDINE HYDROCHLORIDE

06 2DILTIAZEM HYDROCHLORIDE

07 4ESMOLOL HYDROCHLORIDE

08 4LEVETIRACETAM

09 2LINEZOLID

10 6MAGNESIUM SULFATE

11 3MEROPENEM

12 1PACLITAXEL

filter Dosage Reset all filters

35 All

01 15INJECTABLE;INJECTION

02 4INJECTABLE;INTRAVENOUS

03 3POWDER;INTRAVENOUS

04 13SOLUTION;INTRAVENOUS

filter Dosage Strength Reset all filters

35 All

01 10.5MG/ML

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

03 1100MG/100ML (1MG/ML)

04 110MG/VIAL

05 21GM/100ML

06 21GM/100ML (10MG/ML)

07 11GM/50ML (20MG/ML)

08 11GM/VIAL

09 11MG/ML

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

11 1200MG/100ML (2MG/ML)

12 120GM/500ML (40MG/ML)

13 1250MG/250ML (1MG/ML)

14 1250MG/50ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

15 12GM/100ML

16 22GM/100ML (20MG/ML)

17 12GM/50ML (40MG/ML)

18 12GM/VIAL

19 140GM/1000ML (40MG/ML)

20 14GM/100ML (40MG/ML)

21 14GM/50ML (80MG/ML)

22 1500MG/100ML (5MG/ML)

23 1500MG/VIAL

24 150MG/VIAL

25 1600MG/300ML (2MG/ML)

26 16MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

27 1EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)

28 1EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)

29 1EQ 2GM BASE/VIAL

30 1EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)

31 1EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)

32 1EQ 500MG BASE/VIAL;500MG/VIAL

filter Regulatory Info Reset all filters

35 All

01 4DISCN

02 31RX

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01

Brand Name : CALCIUM GLUCONATE IN...

U.S.A

ELCC

Not Confirmed

Brand Name : CALCIUM GLUCONATE IN...

U.S.A

ELCC

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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
Web Link

Stock Recap
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02

Brand Name : CALCIUM GLUCONATE IN...

U.S.A

ELCC

Not Confirmed

Brand Name : CALCIUM GLUCONATE IN...

U.S.A

ELCC

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 : 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

ELCC

Not Confirmed

Brand Name : CALCIUM GLUCONATE IN...

U.S.A

ELCC

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
Web Link

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04

Brand Name : CEFAZOLIN SODIUM

U.S.A

ELCC

Not Confirmed

Brand Name : CEFAZOLIN SODIUM

U.S.A

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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
Web Link

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#PipelineProspector

05

Brand Name : IMIPENEM AND CILASTA...

U.S.A

ELCC

Not Confirmed

Brand Name : IMIPENEM AND CILASTA...

U.S.A

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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

ELCC

Not Confirmed

Brand Name : PLATINOL

U.S.A

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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

ELCC

Not Confirmed

Brand Name : CISPLATIN

U.S.A

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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

ELCC

Not Confirmed

Brand Name : PLATINOL-AQ

U.S.A

ELCC

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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

ELCC

Not Confirmed

Brand Name : CISPLATIN

U.S.A

ELCC

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

ELCC

Not Confirmed

Brand Name : DEXMEDETOMIDINE HYDR...

U.S.A

ELCC

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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