Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080629
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION 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
01/29/1974 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
09/27/2004 SUPPL-218 Labeling

Label is not available on this site.

06/09/2003 SUPPL-215 Labeling

Label is not available on this site.

11/20/2002 SUPPL-210 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/19/1999 SUPPL-208 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/02/1999 SUPPL-207 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

12/04/1996 SUPPL-206 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

05/06/1992 SUPPL-205 Manufacturing (CMC)

Label is not available on this site.

01/11/1991 SUPPL-204 Labeling

Label is not available on this site.

04/09/1990 SUPPL-203 Labeling

Label is not available on this site.

10/12/1989 SUPPL-202 Labeling

Label is not available on this site.

10/12/1989 SUPPL-201 Labeling

Label is not available on this site.

04/11/1989 SUPPL-200 Manufacturing (CMC)

Label is not available on this site.

04/11/1989 SUPPL-199 Manufacturing (CMC)

Label is not available on this site.

08/03/1988 SUPPL-196 Manufacturing (CMC)

Label is not available on this site.

08/03/1988 SUPPL-195 Manufacturing (CMC)

Label is not available on this site.

06/16/1986 SUPPL-191 Manufacturing (CMC)

Label is not available on this site.

11/03/1982 SUPPL-187 Manufacturing (CMC)

Label is not available on this site.

04/23/1982 SUPPL-184 Manufacturing (CMC)

Label is not available on this site.

04/23/1982 SUPPL-155 Manufacturing (CMC)

Label is not available on this site.

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