Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070185
Company: NOVARTIS
Company: NOVARTIS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLUOR-OP | FLUOROMETHOLONE | 0.1% | SUSPENSION/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 |
---|---|---|---|---|---|---|---|
02/27/1986 | 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-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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06/10/1994 | SUPPL-6 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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10/07/1994 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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03/07/1994 | SUPPL-4 | Labeling |
Label is not available on this site. |
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10/20/1992 | SUPPL-3 | Labeling |
Label is not available on this site. |
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06/20/1988 | SUPPL-2 | Labeling |
Label is not available on this site. |
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06/10/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |