U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 040673
Company: QUAGEN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET;ORAL Prescription AB No No
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription AB No No
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG TABLET;ORAL 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
03/05/2008 ORIG-1 Approval

Label is not available on this site.

PROMETHAZINE HYDROCHLORIDE

TABLET;ORAL; 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 TABLET;ORAL Prescription No AB 091179 AMNEAL PHARMS NY
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET;ORAL Prescription No AB 040712 KVK TECH
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET;ORAL Prescription No AB 040622 PRINSTON INC
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET;ORAL Prescription No AB 040673 QUAGEN
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET;ORAL Prescription No AB 209177 STRIDES PHARMA
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET;ORAL Prescription No AB 040863 SUN PHARM INDS INC
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET;ORAL Prescription No AB 040596 ZYDUS PHARMS USA

TABLET;ORAL; 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 TABLET;ORAL Prescription No AB 091179 AMNEAL PHARMS NY
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 040712 KVK TECH
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 040622 PRINSTON INC
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 040673 QUAGEN
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription Yes AB 084176 SANDOZ
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 209177 STRIDES PHARMA
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 040863 SUN PHARM INDS INC
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 083426 WATSON LABS
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 040596 ZYDUS PHARMS USA

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 091179 AMNEAL PHARMS NY
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 040712 KVK TECH
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 040713 KVK TECH
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 040622 PRINSTON INC
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 040673 QUAGEN
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription Yes AB 084176 SANDOZ
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 209177 STRIDES PHARMA
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 040863 SUN PHARM INDS INC
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 083711 WATSON LABS
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 040596 ZYDUS PHARMS USA
Back to Top