Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088762
Company: G AND W LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROMETH W/ DEXTROMETHORPHAN DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SYRUP;ORAL Discontinued None No No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
10/31/1984 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
11/02/2015 SUPPL-74 Labeling

Label is not available on this site.

12/05/2005 SUPPL-60 Labeling

Label is not available on this site.

05/02/2005 SUPPL-55 Labeling

Label is not available on this site.

06/06/2003 SUPPL-52 Labeling

Label is not available on this site.

10/03/2001 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

10/03/2001 SUPPL-50 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/02/2000 SUPPL-49 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/01/2000 SUPPL-46 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/01/2000 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

12/01/1998 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

12/01/1998 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

09/22/1997 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

10/18/1996 SUPPL-40 Labeling

Label is not available on this site.

06/18/1996 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

05/07/1996 SUPPL-37 Labeling

Label is not available on this site.

05/07/1996 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

05/07/1996 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

10/23/1995 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

05/07/1996 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

05/07/1996 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

05/30/1996 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

05/30/1996 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

02/02/1994 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

06/04/1993 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

04/14/1992 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

04/23/1991 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

01/23/1991 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

01/23/1991 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

09/28/1990 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

02/22/1991 SUPPL-21 Labeling

Label is not available on this site.

03/26/1990 SUPPL-20 Labeling

Label is not available on this site.

10/03/1990 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

10/03/1990 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

10/03/1990 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

10/03/1990 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

12/19/1989 SUPPL-14 Labeling

Label is not available on this site.

05/31/1989 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

05/31/1989 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

12/15/1988 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/15/1988 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/02/1988 SUPPL-7 Labeling

Label is not available on this site.

03/17/1987 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

10/09/1987 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/05/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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