Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018746
Company: NOVARTIS
Company: NOVARTIS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VASOCON-A | ANTAZOLINE PHOSPHATE; NAPHAZOLINE HYDROCHLORIDE | 0.5%;0.05% | SOLUTION/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 |
---|---|---|---|---|---|---|---|
04/30/1990 | ORIG-1 | Approval | Type 6 - New Indication (no longer used) | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/02/2001 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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03/06/1997 | SUPPL-9 | Labeling |
Label is not available on this site. |
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03/13/1995 | SUPPL-8 | Labeling |
Label is not available on this site. |
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08/03/1995 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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07/11/1994 | SUPPL-6 | Efficacy-Rx To OTC Switch |
Label is not available on this site. |
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08/22/1995 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/21/1990 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |