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U.S. Department of Health and Human Services

FDA Label Search

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NDC Search Results on Proprietary Name: gemcitabine

Click on Proprietary Name to view the label.

Proprietary Name NDC Company Name Application Number or Regulatory Citation Product Type Marketing Category
GEMCITABINE 16729-391-30  Accord Healthcare Inc.  NDA209604  HUMAN PRESCRIPTION DRUG  NDA 
GEMCITABINE 16729-426-05  Accord Healthcare Inc.  NDA209604  HUMAN PRESCRIPTION DRUG  NDA 
GEMCITABINE 16729-423-33  Accord Healthcare Inc.  NDA209604  HUMAN PRESCRIPTION DRUG  NDA 
GEMCITABINE 16729-419-03  Accord Healthcare Inc.  NDA209604  HUMAN PRESCRIPTION DRUG  NDA 
Gemcitabine 72485-221-02  Armas Pharmaceuticals Inc.  ANDA210991  HUMAN PRESCRIPTION DRUG  ANDA 
Gemcitabine 72485-222-10  Armas Pharmaceuticals Inc.  ANDA210991  HUMAN PRESCRIPTION DRUG  ANDA 
Gemcitabine 72485-223-20  Armas Pharmaceuticals Inc.  ANDA210991  HUMAN PRESCRIPTION DRUG  ANDA 
gemcitabine 55390-391-10  Bedford Laboratories  ANDA091365  HUMAN PRESCRIPTION DRUG  ANDA 
gemcitabine 55390-391-50  Bedford Laboratories  ANDA091365  HUMAN PRESCRIPTION DRUG  ANDA 
GEMCITABINE 68001-359-37  BluePoint Laboratories  NDA209604  HUMAN PRESCRIPTION DRUG  NDA 
GEMCITABINE 68001-342-34  BluePoint Laboratories  NDA209604  HUMAN PRESCRIPTION DRUG  NDA 
GEMCITABINE 68001-348-36  BluePoint Laboratories  NDA209604  HUMAN PRESCRIPTION DRUG  NDA 
GEMCITABINE HYDROCHLORIDE 69097-314-42  Cipla USA Inc.  ANDA078759  HUMAN PRESCRIPTION DRUG  ANDA 
GEMCITABINE HYDROCHLORIDE 69097-313-37  Cipla USA Inc.  ANDA078759  HUMAN PRESCRIPTION DRUG  ANDA 
gemcitabine 55111-687-25  Dr. Reddy's Laboratories Limited  ANDA091365  HUMAN PRESCRIPTION DRUG  ANDA 
gemcitabine 55111-686-07  Dr. Reddy's Laboratories Limited  ANDA091365  HUMAN PRESCRIPTION DRUG  ANDA 
Gemcitabine hydrochloride 62128-0383-6  Evonik Corporation    BULK INGREDIENT  Export only 
Gemcitabine hydrochloride 62128-0383-1  Evonik Corporation    BULK INGREDIENT  Export only 
GEMCITABINE 63323-125-94  Fresenius Kabi USA, LLC  ANDA090799  HUMAN PRESCRIPTION DRUG  ANDA 
GEMCITABINE 63323-102-94  Fresenius Kabi USA, LLC  ANDA090799  HUMAN PRESCRIPTION DRUG  ANDA 
GEMCITABINE 63323-102-13  Fresenius Kabi USA, LLC  ANDA090799  HUMAN PRESCRIPTION DRUG  ANDA 
GEMCITABINE 63323-126-03  Fresenius Kabi USA, LLC  ANDA090799  HUMAN PRESCRIPTION DRUG  ANDA 
GEMCITABINE 63323-125-53  Fresenius Kabi USA, LLC  ANDA090799  HUMAN PRESCRIPTION DRUG  ANDA 
GEMCITABINE 63323-126-00  Fresenius Kabi USA, LLC  ANDA090242  HUMAN PRESCRIPTION DRUG  ANDA 
gemcitabine hydrochloride 68083-148-01  Gland Pharma Limited  ANDA204520  HUMAN PRESCRIPTION DRUG  ANDA 
gemcitabine hydrochloride 68083-149-01  Gland Pharma Limited  ANDA204520  HUMAN PRESCRIPTION DRUG  ANDA 
Gemcitabine 0143-9395-01  Hikma Pharmaceuticals USA Inc.  ANDA206617  HUMAN PRESCRIPTION DRUG  ANDA 
Gemcitabine 0143-9394-01  Hikma Pharmaceuticals USA Inc.  ANDA206617  HUMAN PRESCRIPTION DRUG  ANDA 
Gemcitabine 0409-0181-25  Hospira, Inc.  NDA200795  HUMAN PRESCRIPTION DRUG  NDA 
Gemcitabine 0409-0182-01  Hospira, Inc.  NDA200795  HUMAN PRESCRIPTION DRUG  NDA 
1-30 31-53

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