Product Details for ANDA 210079
OXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE)
325MG;2.5MG
Marketing Status: Discontinued
325MG;5MG
Marketing Status: Discontinued
325MG;7.5MG
Marketing Status: Discontinued
325MG;10MG
Marketing Status: Discontinued
325MG;2.5MG
Marketing Status: Discontinued
Active Ingredient: ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Proprietary Name: OXYCODONE AND ACETAMINOPHEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;2.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A210079
Product Number: 001
Approval Date: Dec 28, 2017
Applicant Holder Full Name: NESHER PHARMACEUTICALS USA LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
OXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE)
Proprietary Name: OXYCODONE AND ACETAMINOPHEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;2.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A210079
Product Number: 001
Approval Date: Dec 28, 2017
Applicant Holder Full Name: NESHER PHARMACEUTICALS USA LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
325MG;5MG
Marketing Status: Discontinued
Active Ingredient: ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Proprietary Name: OXYCODONE AND ACETAMINOPHEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;5MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A210079
Product Number: 002
Approval Date: Dec 28, 2017
Applicant Holder Full Name: NESHER PHARMACEUTICALS USA LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
OXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE)
Proprietary Name: OXYCODONE AND ACETAMINOPHEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;5MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A210079
Product Number: 002
Approval Date: Dec 28, 2017
Applicant Holder Full Name: NESHER PHARMACEUTICALS USA LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
325MG;7.5MG
Marketing Status: Discontinued
Active Ingredient: ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Proprietary Name: OXYCODONE AND ACETAMINOPHEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;7.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A210079
Product Number: 003
Approval Date: Dec 28, 2017
Applicant Holder Full Name: NESHER PHARMACEUTICALS USA LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
OXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE)
Proprietary Name: OXYCODONE AND ACETAMINOPHEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;7.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A210079
Product Number: 003
Approval Date: Dec 28, 2017
Applicant Holder Full Name: NESHER PHARMACEUTICALS USA LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
325MG;10MG
Marketing Status: Discontinued
Active Ingredient: ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Proprietary Name: OXYCODONE AND ACETAMINOPHEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;10MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A210079
Product Number: 004
Approval Date: Dec 28, 2017
Applicant Holder Full Name: NESHER PHARMACEUTICALS USA LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: OXYCODONE AND ACETAMINOPHEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;10MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A210079
Product Number: 004
Approval Date: Dec 28, 2017
Applicant Holder Full Name: NESHER PHARMACEUTICALS USA LLC
Marketing Status: Discontinued
Patent and Exclusivity Information