Drugs@FDA: FDA-Approved Drugs
Company: ALCON LABS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LEVOBUNOLOL HYDROCHLORIDE | LEVOBUNOLOL HYDROCHLORIDE | 0.25% | 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 |
---|---|---|---|---|---|---|---|
10/28/1996 | 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 |
---|---|---|---|---|---|
12/23/2002 | SUPPL-13 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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10/01/2002 | SUPPL-12 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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10/29/2002 | SUPPL-11 | Labeling |
Label is not available on this site. |
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03/27/2002 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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08/02/2002 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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04/07/2000 | SUPPL-7 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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04/28/2000 | SUPPL-6 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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03/23/1999 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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01/21/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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05/07/1999 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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03/04/1999 | SUPPL-2 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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06/04/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |