Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 084176
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription AB No Yes
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET;ORAL Discontinued None No No
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG 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
02/18/1975 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
05/22/2009 SUPPL-62 Labeling

Label is not available on this site.

06/09/2005 SUPPL-59 Labeling

Label is not available on this site.

12/22/2004 SUPPL-57 Labeling

Label is not available on this site.

12/16/2002 SUPPL-54 Manufacturing (CMC)-Control

Label is not available on this site.

04/19/2002 SUPPL-53 Manufacturing (CMC)-Control

Label is not available on this site.

11/20/2002 SUPPL-52 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/23/2001 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

05/05/1999 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

12/15/1998 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

10/03/1996 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

12/01/1995 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

03/17/1995 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

08/28/1991 SUPPL-45 Labeling

Label is not available on this site.

11/01/1988 SUPPL-44 Labeling

Label is not available on this site.

01/03/1986 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

02/07/1985 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

12/13/1983 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

12/13/1983 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

11/02/1983 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

02/01/1983 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

06/23/1982 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

03/23/1982 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

05/01/1981 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

05/12/1982 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

05/12/1982 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

06/23/1982 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

05/12/1982 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

05/12/1982 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

PROMETHAZINE HYDROCHLORIDE

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 No 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

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 No 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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English