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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211544
Company: GRANULES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETAMINOPHEN ACETAMINOPHEN 650MG TABLET, EXTENDED RELEASE;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
04/16/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

ACETAMINOPHEN

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

TABLET, EXTENDED RELEASE;ORAL; 650MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ACETAMINOPHEN ACETAMINOPHEN 650MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 207229 AUROBINDO PHARMA
ACETAMINOPHEN ACETAMINOPHEN 650MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 211544 GRANULES
ACETAMINOPHEN ACETAMINOPHEN 650MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 207035 HERITAGE PHARMA
ACETAMINOPHEN ACETAMINOPHEN 650MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 215486 MARKSANS PHARMA
ACETAMINOPHEN ACETAMINOPHEN 650MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 076200 OHM LABS
ACETAMINOPHEN ACETAMINOPHEN 650MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 075077 PERRIGO
ACETAMINOPHEN ACETAMINOPHEN 650MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 078569 SUN PHARM INDS LTD
TYLENOL ACETAMINOPHEN 650MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter Yes 019872 J AND J CONSUMER INC
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