Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040428
Company: ACP NIMBLE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY;RECTAL Prescription AB No Yes
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 12.5MG 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
02/05/2002 ORIG-1 Approval Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/040428.PDF
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/02/2016 SUPPL-31 Labeling-Container/Carton Labels

Label is not available on this site.
12/18/2012 SUPPL-26 Labeling

Label is not available on this site.
12/18/2012 SUPPL-25 Labeling-Container/Carton Labels

Label is not available on this site.
05/26/2010 SUPPL-24 Labeling-Container/Carton Labels

Label is not available on this site.
04/26/2010 SUPPL-23 Labeling-Container/Carton Labels

Label is not available on this site.
10/13/2005 SUPPL-19 Labeling

Label is not available on this site.
10/06/2004 SUPPL-8 Labeling

Label is not available on this site.
06/18/2004 SUPPL-5 Labeling

Label is not available on this site.
03/31/2003 SUPPL-4 Labeling

Label is not available on this site.
03/31/2003 SUPPL-2 Manufacturing (CMC)-New Strength

Label is not available on this site.
11/20/2002 SUPPL-1 Labeling

Label is not available on this site.

PROMETHAZINE HYDROCHLORIDE

SUPPOSITORY;RECTAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY;RECTAL Prescription No AB 040428 ACP NIMBLE
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY;RECTAL Prescription No AB 040500 PERRIGO ISRAEL
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY;RECTAL Prescription No AB 040603 TARO
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY;RECTAL Prescription No AB 040479 WATSON LABS INC

SUPPOSITORY;RECTAL; 12.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY;RECTAL Prescription No AB 040428 ACP NIMBLE
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY;RECTAL Prescription No AB 040500 PERRIGO ISRAEL
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY;RECTAL Prescription No AB 040603 TARO
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY;RECTAL Prescription No AB 040479 WATSON LABS INC

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