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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040162
Company: IVAX SUB TEVA PHARMS

Products on ANDA 040162

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040162

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/20/1998	ORIG-1	Approval			Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40162ap.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40162ap.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40162ap.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/29/2002	SUPPL-11	Manufacturing (CMC)-Facility		Label is not available on this site.
09/12/2001	SUPPL-9	Manufacturing (CMC)-Facility		Label is not available on this site.
11/13/2000	SUPPL-8	Manufacturing (CMC)-Facility		Label is not available on this site.
11/13/2000	SUPPL-7	Manufacturing (CMC)-Facility		Label is not available on this site.
10/17/2000	SUPPL-6	Labeling		Label is not available on this site.
05/01/2000	SUPPL-5	Manufacturing (CMC)-Facility		Label is not available on this site.
05/01/2000	SUPPL-4	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/28/2000	SUPPL-3	Manufacturing (CMC)-Facility		Label is not available on this site.
11/23/1999	SUPPL-2	Manufacturing (CMC)-Facility		Label is not available on this site.
12/09/1998	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for ANDA 040162

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/20/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40162ap.pdf

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