Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075077
Company: PERRIGO
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
02/25/2000 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75077ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75077_Acetaminophen.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/10/2016 SUPPL-40 Labeling-Package Insert

Label is not available on this site.

11/30/2013 SUPPL-32 Labeling-Package Insert

Label is not available on this site.

10/25/2010 SUPPL-28 Labeling

Label is not available on this site.

02/10/2005 SUPPL-6 Labeling

Label is not available on this site.

12/29/2000 SUPPL-1 Labeling

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 LTD
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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