Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040058
Company: COSETTE

Products on ANDA 040058

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROCHLORPERAZINE	PROCHLORPERAZINE	25MG	SUPPOSITORY;RECTAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040058

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/24/1993	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
01/22/2025	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
02/23/2017	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
10/21/2011	SUPPL-15	Labeling		Label is not available on this site.
12/03/2010	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
07/30/2010	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
06/29/2009	SUPPL-11	Labeling		Label is not available on this site.
09/11/2008	SUPPL-10	Labeling		Label is not available on this site.
09/03/2008	SUPPL-8	Labeling		Label is not available on this site.
06/18/2004	SUPPL-6	Labeling		Label is not available on this site.
11/29/1999	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
04/07/1997	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 040058

PROCHLORPERAZINE

SUPPOSITORY;RECTAL; 25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
COMPRO	PROCHLORPERAZINE	25MG	SUPPOSITORY;RECTAL	Prescription	No	AB	040246	PADAGIS US
PROCHLORPERAZINE	PROCHLORPERAZINE	25MG	SUPPOSITORY;RECTAL	Prescription	No	AB	040058	COSETTE