Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016211
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MIOCHOL | ACETYLCHOLINE CHLORIDE | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION;OPHTHALMIC | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 10/09/1973 | 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 |
|---|---|---|---|---|---|
| 10/16/1996 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 07/30/1996 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 12/04/1987 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 10/31/1990 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 09/04/1985 | SUPPL-18 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 10/17/1988 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 05/08/1984 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 04/29/1985 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 12/06/1983 | SUPPL-14 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 03/30/1987 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 10/24/1986 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 07/20/1981 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/25/1981 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/16/1979 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/10/1977 | SUPPL-8 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |