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Serving 500+ biopharmaceutical companies globally:

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Generated: August 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204549

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NDA 204549 describes GEMCITABINE HYDROCHLORIDE, which is a drug marketed by Gland Pharma Ltd, Luitpold Pharms Inc, Sun Pharma Global, Hospira, Fresenius Kabi Usa, Mylan Labs Ltd, Actavis Inc, Cipla Ltd, Actavis Totowa, Emcure Pharms Ltd, Hameln Rds Gmbh, Dr Reddys Labs Ltd, Apotex Inc, Hospira Inc, Teva Pharms, Jiangsu Hansoh Pharm, Accord Hlthcare, Sagent Pharms, and Fresenius Kabi Oncol, and is included in twenty-one NDAs. It is available from seventeen suppliers. Additional details are available on the GEMCITABINE HYDROCHLORIDE profile page.

The generic ingredient in GEMCITABINE HYDROCHLORIDE is gemcitabine hydrochloride. There are twenty-eight drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the gemcitabine hydrochloride profile page.

Summary for NDA: 204549

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 204549

Suppliers and Packaging for NDA: 204549

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GEMCITABINE HYDROCHLORIDE
gemcitabine hydrochloride
INJECTABLE;INJECTION 204549 ANDA Actavis Pharma, Inc. 45963-623 45963-623-57 1 VIAL, SINGLE-USE in 1 CARTON (45963-623-57) > 26.3 mL in 1 VIAL, SINGLE-USE
GEMCITABINE HYDROCHLORIDE
gemcitabine hydrochloride
INJECTABLE;INJECTION 204549 ANDA Actavis Pharma, Inc. 45963-624 45963-624-58 1 VIAL, SINGLE-USE in 1 CARTON (45963-624-58) > 52.6 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/5.26ML (38MG/ML)
Approval Date:Apr 11, 2016TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1GM/26.3ML (38MG/ML)
Approval Date:Apr 11, 2016TE:APRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2GM/52.6ML (38MG/ML)
Approval Date:Apr 11, 2016TE:APRLD:No


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Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
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Fuji
Baxter
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