Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 214088

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BUTALBITAL AND ACETAMINOPHEN (ACETAMINOPHEN; BUTALBITAL)
300MG;50MG
Marketing Status: Prescription

Active Ingredient: ACETAMINOPHEN; BUTALBITAL
Proprietary Name: BUTALBITAL AND ACETAMINOPHEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG;50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A214088
Product Number: 001
Approval Date: Apr 7, 2022
Applicant Holder Full Name: SENORES PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

BUTALBITAL AND ACETAMINOPHEN (ACETAMINOPHEN; BUTALBITAL)
325MG;25MG
Marketing Status: Prescription

Active Ingredient: ACETAMINOPHEN; BUTALBITAL
Proprietary Name: BUTALBITAL AND ACETAMINOPHEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A214088
Product Number: 002
Approval Date: Apr 7, 2022
Applicant Holder Full Name: SENORES PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

BUTALBITAL AND ACETAMINOPHEN (ACETAMINOPHEN; BUTALBITAL)
325MG;50MG
Marketing Status: Prescription

Active Ingredient: ACETAMINOPHEN; BUTALBITAL
Proprietary Name: BUTALBITAL AND ACETAMINOPHEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A214088
Product Number: 003
Approval Date: Apr 7, 2022
Applicant Holder Full Name: SENORES PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information