Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 040288

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ZYDONE (ACETAMINOPHEN; HYDROCODONE BITARTRATE)
400MG;5MG
Marketing Status: Discontinued

Active Ingredient: ACETAMINOPHEN; HYDROCODONE BITARTRATE
Proprietary Name: ZYDONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 400MG;5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A040288
Product Number: 001
Approval Date: Nov 27, 1998
Applicant Holder Full Name: VINTAGE PHARMACEUTICALS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information

ZYDONE (ACETAMINOPHEN; HYDROCODONE BITARTRATE)
400MG;7.5MG
Marketing Status: Discontinued

Active Ingredient: ACETAMINOPHEN; HYDROCODONE BITARTRATE
Proprietary Name: ZYDONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 400MG;7.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A040288
Product Number: 002
Approval Date: Nov 27, 1998
Applicant Holder Full Name: VINTAGE PHARMACEUTICALS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information

ZYDONE (ACETAMINOPHEN; HYDROCODONE BITARTRATE)
400MG;10MG
Marketing Status: Discontinued

Active Ingredient: ACETAMINOPHEN; HYDROCODONE BITARTRATE
Proprietary Name: ZYDONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 400MG;10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A040288
Product Number: 003
Approval Date: Nov 27, 1998
Applicant Holder Full Name: VINTAGE PHARMACEUTICALS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information