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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 040148

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HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN; HYDROCODONE BITARTRATE)
500MG;10MG
Marketing Status: Discontinued
Active Ingredient: ACETAMINOPHEN; HYDROCODONE BITARTRATE
Proprietary Name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MG;10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A040148
Product Number: 002
Approval Date: Feb 14, 1997
Applicant Holder Full Name: ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
NORCO (ACETAMINOPHEN; HYDROCODONE BITARTRATE)
325MG;2.5MG
Marketing Status: Discontinued
Active Ingredient: ACETAMINOPHEN; HYDROCODONE BITARTRATE
Proprietary Name: NORCO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;2.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A040148
Product Number: 004
Approval Date: Jul 7, 2014
Applicant Holder Full Name: ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
NORCO (ACETAMINOPHEN; HYDROCODONE BITARTRATE)
325MG;5MG
Marketing Status: Discontinued
Active Ingredient: ACETAMINOPHEN; HYDROCODONE BITARTRATE
Proprietary Name: NORCO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A040148
Product Number: 005
Approval Date: Jul 7, 2014
Applicant Holder Full Name: ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
NORCO (ACETAMINOPHEN; HYDROCODONE BITARTRATE)
325MG;7.5MG
Marketing Status: Discontinued
Active Ingredient: ACETAMINOPHEN; HYDROCODONE BITARTRATE
Proprietary Name: NORCO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;7.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A040148
Product Number: 003
Approval Date: Sep 12, 2000
Applicant Holder Full Name: ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
NORCO (ACETAMINOPHEN; HYDROCODONE BITARTRATE)
325MG;10MG
Marketing Status: Discontinued
Active Ingredient: ACETAMINOPHEN; HYDROCODONE BITARTRATE
Proprietary Name: NORCO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A040148
Product Number: 001
Approval Date: Feb 14, 1997
Applicant Holder Full Name: ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
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