Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040246
Company: PADDOCK LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
COMPRO PROCHLORPERAZINE 25MG SUPPOSITORY;RECTAL Prescription AB No No
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.

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 PADDOCK LLC
PROCHLORPERAZINE PROCHLORPERAZINE 25MG SUPPOSITORY;RECTAL Prescription No AB 040058 ACP NIMBLE

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