An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 040191
Company: STRIDES PHARMA

REMS

Products on ANDA 040191

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040191

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
12/15/2023	SUPPL-18	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/15/2023	SUPPL-17	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/13/2023	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-14	REMS - PROPOSAL - D-N-A		Label is not available on this site.
12/13/2023	SUPPL-13	Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert		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.

Labels for ANDA 040191

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

Top