Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062566
Company: NOVARTIS
Company: NOVARTIS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DEXACIDIN | DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM | OINTMENT;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 |
---|---|---|---|---|---|---|---|
02/22/1985 | 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 |
---|---|---|---|---|---|
08/08/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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06/25/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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07/03/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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12/15/1995 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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08/08/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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04/13/1992 | SUPPL-1 | Labeling |
Label is not available on this site. |