Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 083590
Company: RISING
Company: RISING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NAPHAZOLINE HYDROCHLORIDE | NAPHAZOLINE HYDROCHLORIDE | 0.1% | 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 |
|---|---|---|---|---|---|---|---|
| 08/22/1974 | 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 |
|---|---|---|---|---|---|
| 11/30/2012 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/30/2002 | SUPPL-21 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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| 06/07/1999 | SUPPL-20 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 08/25/1999 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/08/1996 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/14/1995 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/14/1995 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/14/1995 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/14/1995 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/14/1995 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/14/1995 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/14/1995 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 09/14/1995 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/14/1995 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/10/1991 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 07/15/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 08/07/1987 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/15/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |