Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040101
Company: CHARTWELL RX

Products on ANDA 040101

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET;ORAL	Discontinued	None	No	No
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET;ORAL	Discontinued	None	No	No
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	EQ 25MG BASE	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040101

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/19/1996	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-19	Labeling-Package Insert		Label is not available on this site.
02/23/2017	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
12/03/2010	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
07/21/2009	SUPPL-15	Labeling		Label is not available on this site.
09/08/2008	SUPPL-14	Labeling		Label is not available on this site.
09/03/2008	SUPPL-13	Labeling		Label is not available on this site.
06/22/2006	SUPPL-10	Labeling		Label is not available on this site.
12/31/2002	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
12/31/2002	SUPPL-5	Manufacturing (CMC)-Facility		Label is not available on this site.
04/03/2002	SUPPL-4	Manufacturing (CMC)-Facility		Label is not available on this site.
04/03/2002	SUPPL-3	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/03/2000	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
08/30/1996	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.