Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 083398
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREDNISOLONE ACETATE PREDNISOLONE 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
02/13/1974 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-143 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/02/1999 SUPPL-142 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

05/27/1998 SUPPL-141 Manufacturing (CMC)

Label is not available on this site.

08/06/1997 SUPPL-140 Manufacturing (CMC)

Label is not available on this site.

05/09/1991 SUPPL-138 Labeling

Label is not available on this site.

10/26/1989 SUPPL-137 Labeling

Label is not available on this site.

01/11/1991 SUPPL-136 Manufacturing (CMC)

Label is not available on this site.

01/11/1991 SUPPL-135 Manufacturing (CMC)

Label is not available on this site.

12/23/1988 SUPPL-134 Manufacturing (CMC)

Label is not available on this site.

12/23/1988 SUPPL-133 Manufacturing (CMC)

Label is not available on this site.

12/30/1988 SUPPL-131 Bioequivalence

Label is not available on this site.

06/16/1986 SUPPL-130 Manufacturing (CMC)

Label is not available on this site.

10/31/1984 SUPPL-129 Manufacturing (CMC)

Label is not available on this site.

06/27/1984 SUPPL-126 Manufacturing (CMC)

Label is not available on this site.

06/27/1984 SUPPL-125 Manufacturing (CMC)

Label is not available on this site.

06/27/1984 SUPPL-83 Manufacturing (CMC)

Label is not available on this site.

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