Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084591
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG/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
09/15/1978 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
04/09/1999 SUPPL-85 Manufacturing (CMC)

Label is not available on this site.

02/19/1999 SUPPL-83 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/02/1999 SUPPL-82 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

12/04/1996 SUPPL-81 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

12/03/1993 SUPPL-80 Manufacturing (CMC)

Label is not available on this site.

09/28/1990 SUPPL-79 Labeling

Label is not available on this site.

02/25/1993 SUPPL-78 Manufacturing (CMC)

Label is not available on this site.

03/28/1990 SUPPL-77 Labeling

Label is not available on this site.

09/22/1989 SUPPL-76 Labeling

Label is not available on this site.

11/18/1988 SUPPL-73 Manufacturing (CMC)

Label is not available on this site.

11/18/1988 SUPPL-72 Manufacturing (CMC)

Label is not available on this site.

07/17/1986 SUPPL-68 Manufacturing (CMC)

Label is not available on this site.

01/12/1983 SUPPL-66 Manufacturing (CMC)

Label is not available on this site.

06/14/1982 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

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