Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062544
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/ML;10,000 UNITS/ML | 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 |
|---|---|---|---|---|---|---|---|
| 10/29/1984 | 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-9 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 02/11/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/10/1994 | SUPPL-5 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 04/24/1995 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/17/1993 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 01/04/1993 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |