Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085953
Company: ACTAVIS MID ATLANTIC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROMETH PLAIN PROMETHAZINE HYDROCHLORIDE 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
08/21/1978 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
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.

12/13/2001 SUPPL-49 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/20/2000 SUPPL-48 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/17/1999 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

06/17/1999 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

08/04/1997 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

01/16/1997 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

07/05/1996 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

08/08/1996 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

08/08/1996 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

08/08/1996 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

08/08/1996 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

10/30/1997 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

10/30/1997 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

06/04/1993 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

12/27/1990 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

05/01/1990 SUPPL-22 Labeling

Label is not available on this site.

05/01/1990 SUPPL-21 Labeling

Label is not available on this site.

11/21/1989 SUPPL-20 Labeling

Label is not available on this site.

05/16/1990 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

02/08/1989 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

02/08/1989 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

02/12/1986 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

04/05/1985 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/25/1983 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

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