Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 076200
Company: OHM LABS
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
03/19/2002 ORIG-1 Approval Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76200.apd.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076200_s000_AcetaminophenTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/23/2015 SUPPL-22 Labeling-Package Insert

Label is not available on this site.

09/25/2014 SUPPL-21 Labeling-Container/Carton Labels

Label is not available on this site.

09/25/2014 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

09/25/2014 SUPPL-19 Labeling-Container/Carton Labels

Label is not available on this site.

07/28/2010 SUPPL-16 Labeling-Container/Carton Labels

Label is not available on this site.

01/22/2010 SUPPL-15 Labeling-Container/Carton Labels

Label is not available on this site.

11/23/2009 SUPPL-14 Labeling-Container/Carton Labels

Label is not available on this site.

02/17/2009 SUPPL-12 Labeling

Label is not available on this site.

08/11/2004 SUPPL-5 Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076200_S005_AcetaminophenTOC.cfm
12/03/2002 SUPPL-4 Manufacturing (CMC)-Packaging Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076200_s001s002s003s004_AcetaminophenTOC.cfm
12/03/2002 SUPPL-3 Manufacturing (CMC)-Facility Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076200_s001s002s003s004_AcetaminophenTOC.cfm
12/03/2002 SUPPL-2 Manufacturing (CMC)-Facility Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076200_s001s002s003s004_AcetaminophenTOC.cfm
10/15/2002 SUPPL-1 Manufacturing (CMC)-Control Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076200_s001_AcetaminophenTOC.cfm

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English