Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020219
Company: NOVARTIS
Company: NOVARTIS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LIVOSTIN | LEVOCABASTINE HYDROCHLORIDE | EQ 0.05% BASE | 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 |
---|---|---|---|---|---|---|---|
11/10/1993 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/26/2000 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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02/23/1999 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/02/1998 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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04/30/1997 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/14/1996 | SUPPL-4 | Labeling |
Label is not available on this site. |
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06/10/1996 | SUPPL-3 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
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03/23/1995 | SUPPL-2 | Labeling |
Label is not available on this site. |
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10/24/1994 | SUPPL-1 | Labeling |
Label is not available on this site. |