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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 091633

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HYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE; IBUPROFEN)
2.5MG;200MG
Marketing Status: Discontinued
Active Ingredient: HYDROCODONE BITARTRATE; IBUPROFEN
Proprietary Name: HYDROCODONE BITARTRATE AND IBUPROFEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG;200MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A091633
Product Number: 001
Approval Date: May 28, 2013
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
HYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE; IBUPROFEN)
5MG;200MG
Marketing Status: Discontinued
Active Ingredient: HYDROCODONE BITARTRATE; IBUPROFEN
Proprietary Name: HYDROCODONE BITARTRATE AND IBUPROFEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG;200MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A091633
Product Number: 002
Approval Date: May 28, 2013
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
HYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE; IBUPROFEN)
7.5MG;200MG
Marketing Status: Discontinued
Active Ingredient: HYDROCODONE BITARTRATE; IBUPROFEN
Proprietary Name: HYDROCODONE BITARTRATE AND IBUPROFEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 7.5MG;200MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A091633
Product Number: 003
Approval Date: May 28, 2013
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
HYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE; IBUPROFEN)
10MG;200MG
Marketing Status: Discontinued
Active Ingredient: HYDROCODONE BITARTRATE; IBUPROFEN
Proprietary Name: HYDROCODONE BITARTRATE AND IBUPROFEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG;200MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A091633
Product Number: 004
Approval Date: May 28, 2013
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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