Drugs@FDA: FDA-Approved Drugs
Company: ABBVIE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PRED FORTE | 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 |
|---|---|---|---|---|---|---|---|
| 05/30/1973 | 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 |
|---|---|---|---|---|---|
| 06/06/2018 | SUPPL-50 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017011s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017011Orig1s050ltr.pdf | |
| 05/04/2017 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017011s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017011Orig1s047ltr.pdf | |
| 04/12/2002 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/04/2001 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/28/2001 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/24/2001 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/12/2001 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/02/2000 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/19/1998 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/30/1997 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/05/1996 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/10/1995 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/03/1995 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/30/1989 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/12/1989 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/09/1988 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/17/1988 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 11/03/1987 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/30/1987 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/13/1986 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/13/1986 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/15/1986 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 08/13/1982 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/11/1983 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/03/1982 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/02/1982 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/22/1980 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/19/1979 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/05/1975 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 11/26/1974 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/06/2018 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017011s050lbl.pdf | |
| 05/04/2017 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017011s047lbl.pdf |
PRED FORTE
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 |