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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214039
Company: GRANULES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETAMINOPHEN, ASPIRIN AND CAFFEINE ACETAMINOPHEN; ASPIRIN; CAFFEINE 250MG;250MG;65MG TABLET;ORAL Over-the-counter None 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
02/23/2021 ORIG-1 Approval STANDARD

Label is not available on this site.

ACETAMINOPHEN, ASPIRIN AND CAFFEINE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET;ORAL; 250MG;250MG;65MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ACETAMINOPHEN, ASPIRIN AND CAFFEINE ACETAMINOPHEN; ASPIRIN; CAFFEINE 250MG;250MG;65MG TABLET;ORAL Over-the-counter No 211695 AUROBINDO PHARMA LTD
ACETAMINOPHEN, ASPIRIN AND CAFFEINE ACETAMINOPHEN; ASPIRIN; CAFFEINE 250MG;250MG;65MG TABLET;ORAL Over-the-counter No 214039 GRANULES
ACETAMINOPHEN, ASPIRIN AND CAFFEINE ACETAMINOPHEN; ASPIRIN; CAFFEINE 250MG;250MG;65MG TABLET;ORAL Over-the-counter No 075794 PERRIGO
EXCEDRIN (MIGRAINE) ACETAMINOPHEN; ASPIRIN; CAFFEINE 250MG;250MG;65MG TABLET;ORAL Over-the-counter Yes 020802 GLAXOSMITHKLINE CONS
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