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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040893
Company: GENUS

REMS

Products on ANDA 040893

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	AA	No	No
MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	75MG	TABLET;ORAL	Discontinued	None	No	No
MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	100MG	TABLET;ORAL	Discontinued	None	No	No
MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	150MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040893

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/24/2009	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-8	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/31/2024	SUPPL-7	REMS - MODIFIED - D-N-A		Label is not available on this site.
12/15/2023	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/13/2023	SUPPL-5	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-4	REMS - PROPOSAL - D-N-A		Label is not available on this site.
12/13/2023	SUPPL-3	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 040893

MEPERIDINE HYDROCHLORIDE

TABLET;ORAL; 50MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AA	040331	EPIC PHARMA LLC
MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AA	040893	GENUS

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