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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040331
Company: EPIC PHARMA LLC

REMS

Products on ANDA 040331

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040331

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/28/1999	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40331ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/12/2024	SUPPL-22	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/12/2024	SUPPL-21	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/22/2024	SUPPL-20	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/17/2020	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
12/17/2020	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-16	REMS - PROPOSAL - D-N-A		Label is not available on this site.
12/17/2020	SUPPL-15	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/21/2013	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
08/31/2012	SUPPL-10	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
12/17/2004	SUPPL-6	Labeling		Label is not available on this site.
09/07/2004	SUPPL-4	Labeling		Label is not available on this site.
06/03/2004	SUPPL-3	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 040331

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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