Drugs@FDA: FDA-Approved Drugs
Company: ALLERGAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OPTICROM | CROMOLYN SODIUM | 4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS;OPHTHALMIC | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 10/03/1984 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD; Orphan |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/19/2003 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 04/12/2002 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/04/2001 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/12/2001 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/24/2001 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/13/2001 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 10/02/2000 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/03/1998 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/11/1993 | SUPPL-18 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
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| 07/22/1992 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 10/13/1992 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/09/1990 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/04/1989 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 09/23/1987 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/23/1987 | SUPPL-10 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 10/24/1986 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/12/1987 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/02/1986 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/20/1986 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/28/1985 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/23/1985 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/24/1985 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/16/1985 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |