Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088761
Company: G AND W LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROMETH VC PLAIN PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE 5MG/5ML;6.25MG/5ML 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
11/08/1984 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
08/01/2011 SUPPL-78 Labeling

Label is not available on this site.

10/06/2005 SUPPL-64 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-49 Labeling

Label is not available on this site.

10/03/2001 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

10/03/2001 SUPPL-47 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/02/2000 SUPPL-46 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/01/1998 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

12/01/1998 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

09/02/1997 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

11/08/1996 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

06/18/1996 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

05/07/1996 SUPPL-35 Labeling

Label is not available on this site.

05/07/1996 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.

10/23/1995 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

05/07/1996 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

05/07/1996 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

05/30/1996 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

05/30/1996 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

02/02/1994 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

09/27/1991 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

04/23/1991 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

09/28/1990 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

12/06/1990 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

06/01/1990 SUPPL-21 Labeling

Label is not available on this site.

12/22/1989 SUPPL-20 Labeling

Label is not available on this site.

05/25/1990 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/25/1990 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

05/25/1990 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

12/15/1988 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

03/17/1987 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/18/1986 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/18/1986 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/18/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/13/1987 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/13/1987 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/14/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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