Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080751
Company: NOVARTIS
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 | Yes | No |
| INFLAMASE MILD | PREDNISOLONE SODIUM PHOSPHATE | EQ 0.11% PHOSPHATE | SOLUTION/DROPS;OPHTHALMIC | Discontinued | None | Yes | 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. |
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| 10/15/1996 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 10/15/1996 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/10/1994 | SUPPL-19 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 10/26/1994 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/02/1992 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 04/01/1991 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 06/02/1989 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/02/1989 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/02/1989 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/02/1989 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/02/1989 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/02/1989 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 06/17/1988 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 08/15/1986 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |