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Generated: November 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090943

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NDA 090943 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 090943

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

Pharmacology for NDA: 090943

Medical Subject Heading (MeSH) Categories for 090943

Suppliers and Packaging for NDA: 090943

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPECITABINE
capecitabine
TABLET;ORAL 090943 ANDA KAISER FOUNDATION HOSPITALS 0179-0195 0179-0195-70 30 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0179-0195-70)
CAPECITABINE
capecitabine
TABLET;ORAL 090943 ANDA Mylan Pharmaceuticals Inc. 0378-2511 0378-2511-91 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2511-91)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Aug 8, 2014TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Aug 8, 2014TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

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