Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040069
Company: BAUSCH AND LOMB
Company: BAUSCH AND LOMB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE | EQ 0.1% PHOSPHATE | SOLUTION/DROPS;OPHTHALMIC, OTIC | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/26/1996 | 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 |
|---|---|---|---|---|---|
| 12/23/2002 | SUPPL-15 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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| 11/27/2001 | SUPPL-14 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 04/30/2001 | SUPPL-13 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 03/07/2001 | SUPPL-12 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 06/27/2000 | SUPPL-11 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 04/28/2000 | SUPPL-9 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 05/18/2000 | SUPPL-8 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 06/07/1999 | SUPPL-7 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 08/27/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/19/1998 | SUPPL-5 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 02/10/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/13/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/16/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |