Product Details for ANDA 203863
HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN; HYDROCODONE BITARTRATE)
325MG;5MG
Marketing Status: Prescription
325MG;7.5MG
Marketing Status: Prescription
325MG;10MG
Marketing Status: Prescription
325MG;5MG
Marketing Status: Prescription
Active Ingredient: ACETAMINOPHEN; HYDROCODONE BITARTRATE
Proprietary Name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A203863
Product Number: 001
Approval Date: Mar 30, 2018
Applicant Holder Full Name: EPIC PHARMA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN; HYDROCODONE BITARTRATE)
Proprietary Name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A203863
Product Number: 001
Approval Date: Mar 30, 2018
Applicant Holder Full Name: EPIC PHARMA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
325MG;7.5MG
Marketing Status: Prescription
Active Ingredient: ACETAMINOPHEN; HYDROCODONE BITARTRATE
Proprietary Name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;7.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A203863
Product Number: 002
Approval Date: Mar 30, 2018
Applicant Holder Full Name: EPIC PHARMA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN; HYDROCODONE BITARTRATE)
Proprietary Name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;7.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A203863
Product Number: 002
Approval Date: Mar 30, 2018
Applicant Holder Full Name: EPIC PHARMA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
325MG;10MG
Marketing Status: Prescription
Active Ingredient: ACETAMINOPHEN; HYDROCODONE BITARTRATE
Proprietary Name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A203863
Product Number: 003
Approval Date: Mar 30, 2018
Applicant Holder Full Name: EPIC PHARMA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A203863
Product Number: 003
Approval Date: Mar 30, 2018
Applicant Holder Full Name: EPIC PHARMA LLC
Marketing Status: Prescription
Patent and Exclusivity Information