Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040246
Company: PADAGIS US

Products on ANDA 040246

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040246

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/28/2000	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40246ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40246_Compro.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/23/2017	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
10/25/2011	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
12/03/2010	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
07/07/2009	SUPPL-8	Labeling		Label is not available on this site.
03/03/2009	SUPPL-7	Labeling		Label is not available on this site.
05/15/2008	SUPPL-6	Labeling		Label is not available on this site.
02/09/2001	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Therapeutic Equivalents for ANDA 040246

COMPRO

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