Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040191
Company: VINTAGE PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE 50MG TABLET;ORAL Discontinued None No No
MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE 100MG TABLET;ORAL Discontinued 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
12/17/1998 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40191_Meperidine%20Hydrochloride_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40191ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/040191_meperidine_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/18/2018 SUPPL-14 REMS - PROPOSAL - D-N-A

Label is not available on this site.

01/06/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

10/18/2011 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

07/01/2009 SUPPL-5 Labeling

Label is not available on this site.

10/06/2005 SUPPL-4 Labeling

Label is not available on this site.

07/07/2005 SUPPL-3 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/17/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40191_Meperidine%20Hydrochloride_Prntlbl.pdf

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