Product Details for ANDA 202214
HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN; HYDROCODONE BITARTRATE)
300MG;5MG
Marketing Status: Prescription
300MG;7.5MG
Marketing Status: Prescription
300MG;10MG
Marketing Status: Prescription
325MG;5MG
Marketing Status: Prescription
325MG;7.5MG
Marketing Status: Prescription
325MG;10MG
Marketing Status: Prescription
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: No
TE Code: AA
Application Number: A202214
Product Number: 004
Approval Date: Mar 15, 2016
Applicant Holder Full Name: TRIS PHARMA INC
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: 300MG;5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A202214
Product Number: 004
Approval Date: Mar 15, 2016
Applicant Holder Full Name: TRIS PHARMA INC
Marketing Status: Prescription
Patent and Exclusivity Information
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: No
TE Code: AA
Application Number: A202214
Product Number: 005
Approval Date: Mar 15, 2016
Applicant Holder Full Name: TRIS PHARMA INC
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: 300MG;7.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A202214
Product Number: 005
Approval Date: Mar 15, 2016
Applicant Holder Full Name: TRIS PHARMA INC
Marketing Status: Prescription
Patent and Exclusivity Information
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: No
TE Code: AA
Application Number: A202214
Product Number: 006
Approval Date: Mar 15, 2016
Applicant Holder Full Name: TRIS PHARMA INC
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: 300MG;10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A202214
Product Number: 006
Approval Date: Mar 15, 2016
Applicant Holder Full Name: TRIS PHARMA INC
Marketing Status: Prescription
Patent and Exclusivity Information
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: A202214
Product Number: 001
Approval Date: Mar 27, 2013
Applicant Holder Full Name: TRIS PHARMA INC
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: A202214
Product Number: 001
Approval Date: Mar 27, 2013
Applicant Holder Full Name: TRIS PHARMA INC
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: A202214
Product Number: 002
Approval Date: Mar 27, 2013
Applicant Holder Full Name: TRIS PHARMA INC
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: A202214
Product Number: 002
Approval Date: Mar 27, 2013
Applicant Holder Full Name: TRIS PHARMA INC
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: A202214
Product Number: 003
Approval Date: Mar 27, 2013
Applicant Holder Full Name: TRIS PHARMA INC
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: A202214
Product Number: 003
Approval Date: Mar 27, 2013
Applicant Holder Full Name: TRIS PHARMA INC
Marketing Status: Prescription
Patent and Exclusivity Information