Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040446
Company: SUN PHARM INDS INC

• REMS

Products on ANDA 040446

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 040446

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/08/2002	ORIG-1	Approval			Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40446ltr.pdf https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-14	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/15/2023	SUPPL-13	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/13/2023	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-11	REMS - PROPOSAL - D-N-A		Label is not available on this site.
06/23/2009	SUPPL-7	Labeling		Label is not available on this site.
09/12/2006	SUPPL-1	Labeling		Label is not available on this site.