Drugs@FDA: FDA-Approved Drugs
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OMNIPRED | PREDNISOLONE ACETATE | 1% | SUSPENSION/DROPS;OPHTHALMIC | Prescription | AB | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 07/10/1973 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
|---|---|---|---|---|---|
| 03/04/2022 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017469Orig1s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/017469Orig1s047ltr.pdf | |
| 10/11/2007 | SUPPL-40 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017469s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017469s040ltr.pdf | |
| 05/15/2006 | SUPPL-38 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017469s35s38lbl.pdf | |
| 05/15/2006 | SUPPL-35 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017469s35s38lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017469s035LTR.pdf | |
| 04/17/2003 | SUPPL-31 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17468slr019,17469slr031_econopred_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17468slr019,17469slr031ltr.pdf | |
| 12/11/2002 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/04/2002 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/16/2000 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/17/1999 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/05/1999 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/09/1999 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/06/1998 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/04/1998 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/27/1997 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/18/1996 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/05/1996 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/01/1995 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/29/1995 | SUPPL-18 | Efficacy-Accelerated Approval Confirmatory Study |
Label is not available on this site. |
||
| 11/01/1995 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/13/1995 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/10/1991 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/22/1991 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 03/02/1988 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/12/1986 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/06/1989 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 05/25/1982 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/24/1979 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/24/1977 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 04/06/1977 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/06/1977 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/06/1977 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/06/1977 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/05/1974 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/04/2022 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017469Orig1s047lbl.pdf | |
| 10/11/2007 | SUPPL-40 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017469s040lbl.pdf | |
| 05/15/2006 | SUPPL-38 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017469s35s38lbl.pdf | |
| 05/15/2006 | SUPPL-35 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017469s35s38lbl.pdf | |
| 04/17/2003 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17468slr019,17469slr031_econopred_lbl.pdf |
OMNIPRED
SUSPENSION/DROPS;OPHTHALMIC; 1%
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OMNIPRED | PREDNISOLONE ACETATE | 1% | SUSPENSION/DROPS;OPHTHALMIC | Prescription | Yes | AB | 017469 | SANDOZ |
| PRED FORTE | PREDNISOLONE ACETATE | 1% | SUSPENSION/DROPS;OPHTHALMIC | Prescription | Yes | AB | 017011 | ABBVIE |