Drugs@FDA: FDA-Approved Drugs
Company: NOVARTIS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OCUPRESS | CARTEOLOL HYDROCHLORIDE | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS;OPHTHALMIC | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
05/23/1990 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
---|---|---|---|---|---|
05/22/2001 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/29/2001 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/26/2000 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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12/18/1998 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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11/24/1997 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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10/22/1996 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/20/1997 | SUPPL-12 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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08/06/1996 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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08/06/1996 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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04/01/1996 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/31/1996 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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05/20/1996 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/20/1996 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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05/20/1996 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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03/18/1996 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/18/1996 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/16/1996 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/20/1994 | SUPPL-1 | Labeling |
Label is not available on this site. |