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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204649
Company: STRIDES PHARMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325MG;50MG;40MG;30MG CAPSULE;ORAL Prescription AB No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/08/2020 ORIG-1 Approval

Label is not available on this site.

BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE

CAPSULE;ORAL; 325MG;50MG;40MG;30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325MG;50MG;40MG;30MG CAPSULE;ORAL Prescription No AB 215138 HIKMA
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325MG;50MG;40MG;30MG CAPSULE;ORAL Prescription No AB 076560 LGM PHARMA
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325MG;50MG;40MG;30MG CAPSULE;ORAL Prescription No AB 204649 STRIDES PHARMA
FIORICET W/ CODEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325MG;50MG;40MG;30MG CAPSULE;ORAL Prescription Yes AB 020232 ACTAVIS LABS UT INC
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