Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 040658

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HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN; HYDROCODONE BITARTRATE)
300MG;5MG
Marketing Status: Prescription

Active Ingredient: ACETAMINOPHEN; HYDROCODONE BITARTRATE
Proprietary Name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG;5MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AA
Application Number: A040658
Product Number: 001
Approval Date: Jan 19, 2006
Applicant Holder Full Name: CHARTWELL SCHEDULED LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN; HYDROCODONE BITARTRATE)
300MG;7.5MG
Marketing Status: Prescription

Active Ingredient: ACETAMINOPHEN; HYDROCODONE BITARTRATE
Proprietary Name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG;7.5MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AA
Application Number: A040658
Product Number: 002
Approval Date: Mar 24, 2006
Applicant Holder Full Name: CHARTWELL SCHEDULED LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN; HYDROCODONE BITARTRATE)
300MG;10MG
Marketing Status: Prescription

Active Ingredient: ACETAMINOPHEN; HYDROCODONE BITARTRATE
Proprietary Name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG;10MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AA
Application Number: A040658
Product Number: 003
Approval Date: Jun 23, 2004
Applicant Holder Full Name: CHARTWELL SCHEDULED LLC
Marketing Status:  Prescription
Patent and Exclusivity Information