Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 008883
Company: APOTHECON
Company: APOTHECON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OPHTHAINE | PROPARACAINE HYDROCHLORIDE | 0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS;OPHTHALMIC | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 07/01/1953 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 08/08/1988 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/05/1986 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/03/1984 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 07/26/1985 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/22/1983 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/08/1982 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 10/04/1979 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/24/1978 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/28/1978 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 09/28/1978 | SUPPL-5 | Labeling |
Label is not available on this site. |