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Product Details for ANDA 213115

BUTALBITAL AND ACETAMINOPHEN (ACETAMINOPHEN; BUTALBITAL)
300MG;50MG
Marketing Status: Prescription
Active Ingredient: ACETAMINOPHEN; BUTALBITAL
Proprietary Name: BUTALBITAL AND ACETAMINOPHEN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 300MG;50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A213115
Product Number: 001
Approval Date: Nov 22, 2019
Applicant Holder Full Name: GRANULES PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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