Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 083128
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCORTISONE ACETATE HYDROCORTISONE ACETATE 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
02/27/1979 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
02/19/1999 SUPPL-68 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/02/1999 SUPPL-67 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

06/09/1998 SUPPL-66 Manufacturing (CMC)

Label is not available on this site.

06/16/1997 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

09/03/1996 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

11/30/1994 SUPPL-63 Labeling

Label is not available on this site.

02/24/1994 SUPPL-62 Labeling

Label is not available on this site.

10/29/1992 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

01/26/1993 SUPPL-60 Bioequivalence

Label is not available on this site.

04/01/1991 SUPPL-59 Labeling

Label is not available on this site.

05/22/1992 SUPPL-58 Labeling

Label is not available on this site.

11/15/1989 SUPPL-57 Labeling

Label is not available on this site.

02/11/1991 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

02/11/1991 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

07/30/1992 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

12/23/1988 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

12/23/1988 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

12/23/1988 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

12/23/1988 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

06/16/1986 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

05/27/1983 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

06/30/1982 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

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