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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 040330

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PERCOCET (ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE)
325MG;2.5MG
Marketing Status: Prescription
Active Ingredient: ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Proprietary Name: PERCOCET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;2.5MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AA
Application Number: A040330
Product Number: 001
Approval Date: Jun 25, 1999
Applicant Holder Full Name: VINTAGE PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
PERCOCET (ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE)
325MG;5MG
Marketing Status: Prescription
Active Ingredient: ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Proprietary Name: PERCOCET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;5MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AA
Application Number: A040330
Product Number: 002
Approval Date: Jun 25, 1999
Applicant Holder Full Name: VINTAGE PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
PERCOCET (ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE)
325MG;7.5MG
Marketing Status: Prescription
Active Ingredient: ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Proprietary Name: PERCOCET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;7.5MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AA
Application Number: A040330
Product Number: 003
Approval Date: Nov 23, 2001
Applicant Holder Full Name: VINTAGE PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
PERCOCET (ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE)
325MG;10MG
Marketing Status: Prescription
Active Ingredient: ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Proprietary Name: PERCOCET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;10MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AA
Application Number: A040330
Product Number: 004
Approval Date: Nov 23, 2001
Applicant Holder Full Name: VINTAGE PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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