Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080751
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INFLAMASE FORTE PREDNISOLONE SODIUM PHOSPHATE EQ 0.9% PHOSPHATE SOLUTION/DROPS;OPHTHALMIC Discontinued None No No
INFLAMASE MILD PREDNISOLONE SODIUM PHOSPHATE EQ 0.11% PHOSPHATE SOLUTION/DROPS;OPHTHALMIC 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
12/19/1973 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
04/19/2001 SUPPL-22 Manufacturing (CMC)-Facility

Label is not available on this site.

10/15/1996 SUPPL-21 Labeling

Label is not available on this site.

10/15/1996 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

06/10/1994 SUPPL-19 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/26/1994 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

11/02/1992 SUPPL-17 Labeling

Label is not available on this site.

04/01/1991 SUPPL-16 Labeling

Label is not available on this site.

06/02/1989 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

06/02/1989 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

06/02/1989 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/02/1989 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

06/02/1989 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

06/02/1989 SUPPL-10 Labeling

Label is not available on this site.

06/17/1988 SUPPL-9 Labeling

Label is not available on this site.

08/15/1986 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

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