Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080248
Company: ALLERGAN
Company: ALLERGAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALBALON | NAPHAZOLINE HYDROCHLORIDE | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS;OPHTHALMIC | Discontinued | None | No | No |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 |
|---|---|---|---|---|---|---|---|
| 03/24/1972 | 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 |
|---|---|---|---|---|---|
| 11/15/2002 | SUPPL-42 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 07/03/2002 | SUPPL-40 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 11/15/2001 | SUPPL-39 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 08/15/2001 | SUPPL-38 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 12/08/2000 | SUPPL-37 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 08/24/1998 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/18/1999 | SUPPL-35 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 09/29/1997 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/29/1997 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/21/1995 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/21/1995 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/27/1994 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/07/1992 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/25/1991 | SUPPL-28 | Labeling |
Label is not available on this site. |
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| 01/20/1988 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/05/1987 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/12/1983 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |