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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040058
Company: COSETTE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROCHLORPERAZINE PROCHLORPERAZINE 25MG SUPPOSITORY;RECTAL Prescription AB No Yes
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
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.

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
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