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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 204649

BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE (ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE)
325MG;50MG;40MG;30MG
Marketing Status: Prescription
Active Ingredient: ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
Proprietary Name: BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 325MG;50MG;40MG;30MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204649
Product Number: 001
Approval Date: Jul 8, 2020
Applicant Holder Full Name: STRIDES PHARMA GLOBAL PTE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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