Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 076560

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BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE (ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE)
300MG;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: 300MG;50MG;40MG;30MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076560
Product Number: 002
Approval Date: Jul 19, 2012
Applicant Holder Full Name: LGM PHARMA SOLUTIONS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

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: A076560
Product Number: 001
Approval Date: Jun 10, 2004
Applicant Holder Full Name: LGM PHARMA SOLUTIONS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information