Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 040110
Company: HIKMA

• REMS

Products on ANDA 040110

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 040110

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/12/1997	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/22/2025	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
10/31/2024	SUPPL-13	REMS - MODIFIED - D-N-A		Label is not available on this site.
08/13/2024	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
12/15/2023	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
12/14/2023	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
03/04/2021	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
10/08/2019	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
10/04/2019	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-6	REMS - PROPOSAL - D-N-A		Label is not available on this site.
04/28/2017	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
03/30/2012	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
05/17/2011	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
04/28/2009	SUPPL-2	Labeling		Label is not available on this site.
09/26/2005	SUPPL-1	Labeling		Label is not available on this site.