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Generated: August 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200483

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NDA 200483 describes CAPECITABINE, which is a drug marketed by Amneal Pharms, Mylan Pharms Inc, Teva Pharms Usa, Shilpa Medicare Ltd, West-ward Pharms Int, and Accord Hlthcare, and is included in six NDAs. It is available from twelve suppliers. Additional details are available on the CAPECITABINE profile page.

The generic ingredient in CAPECITABINE is capecitabine. There are twenty-eight drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the capecitabine profile page.

Summary for NDA: 200483

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

Pharmacology for NDA: 200483

Suppliers and Packaging for NDA: 200483

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPECITABINE
capecitabine
TABLET;ORAL 200483 ANDA West-Ward Pharmaceuticals Corp. 0054-0271 0054-0271-21 60 TABLET, FILM COATED in 1 BOTTLE (0054-0271-21)
CAPECITABINE
capecitabine
TABLET;ORAL 200483 ANDA West-Ward Pharmaceuticals Corp. 0054-0272 0054-0272-23 120 TABLET, FILM COATED in 1 BOTTLE (0054-0272-23)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Jul 14, 2016TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Jul 14, 2016TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

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Cipla
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