Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087165
Company: ACP NIMBLE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROMETHEGAN PROMETHAZINE HYDROCHLORIDE 50MG SUPPOSITORY;RECTAL Prescription None 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
08/14/1987 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/087165ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/07/2016 SUPPL-24 Labeling-Container/Carton Labels

Label is not available on this site.

12/30/2012 SUPPL-21 Labeling

Label is not available on this site.

12/30/2012 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

06/16/2004 SUPPL-16 Labeling

Label is not available on this site.

06/16/2004 SUPPL-12 Labeling

Label is not available on this site.

11/04/2002 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

03/04/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/01/1993 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/08/1991 SUPPL-3 Labeling

Label is not available on this site.

05/15/1991 SUPPL-2 Labeling

Label is not available on this site.

07/23/1991 SUPPL-1 Labeling

Label is not available on this site.

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