Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040186
Company: WATSON LABS

• REMS

Products on ANDA 040186

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 040186

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/30/1997	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-15	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/31/2024	SUPPL-14	REMS - MODIFIED - D-N-A		Label is not available on this site.
04/30/2024	SUPPL-13	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/15/2023	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/15/2023	SUPPL-11	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/13/2023	SUPPL-10	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/18/2018	SUPPL-9	REMS - PROPOSAL - D-N-A		Label is not available on this site.
08/16/2004	SUPPL-6	Labeling		Label is not available on this site.
04/12/2001	SUPPL-5	Manufacturing (CMC)-Facility		Label is not available on this site.
03/21/2000	SUPPL-4	Manufacturing (CMC)-Facility		Label is not available on this site.
08/21/1998	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
10/22/1997	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.