Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040479
Company: WATSON LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY;RECTAL Prescription AB No No
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 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
06/24/2003 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
04/20/2004 SUPPL-1 Labeling

Label is not available on this site.

PROMETHAZINE HYDROCHLORIDE

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

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

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