Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 083764
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREDNISOLONE ACETATE PREDNISOLONE ACETATE 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
02/13/1974 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
02/19/1999 SUPPL-195 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/02/1999 SUPPL-194 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

06/08/1998 SUPPL-193 Manufacturing (CMC)

Label is not available on this site.

01/24/1997 SUPPL-192 Manufacturing (CMC)

Label is not available on this site.

04/15/1991 SUPPL-190 Labeling

Label is not available on this site.

11/08/1989 SUPPL-189 Labeling

Label is not available on this site.

01/11/1991 SUPPL-188 Manufacturing (CMC)

Label is not available on this site.

01/11/1991 SUPPL-187 Manufacturing (CMC)

Label is not available on this site.

12/30/1988 SUPPL-182 Bioequivalence

Label is not available on this site.

06/16/1986 SUPPL-181 Manufacturing (CMC)

Label is not available on this site.

10/31/1984 SUPPL-180 Manufacturing (CMC)

Label is not available on this site.

09/17/1982 SUPPL-179 Manufacturing (CMC)

Label is not available on this site.

05/19/1982 SUPPL-178 Manufacturing (CMC)

Label is not available on this site.

04/05/1982 SUPPL-177 Manufacturing (CMC)

Label is not available on this site.

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