Drugs@FDA: FDA-Approved Drugs
Company: ABBVIE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PRED MILD | PREDNISOLONE ACETATE | 0.12% | SUSPENSION/DROPS;OPHTHALMIC | Prescription | None | 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 |
|---|---|---|---|---|---|---|---|
| 11/10/1972 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
|---|---|---|---|---|---|
| 12/08/2022 | SUPPL-48 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017100s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/017100Orig1s048ltr.pdf | |
| 12/08/2022 | SUPPL-46 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/06/2018 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017100s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017100Orig1s045ltr_Redacted.pdf | |
| 05/04/2017 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017100s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017100Orig1s044ltr.pdf | |
| 03/19/2003 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 04/12/2002 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/04/2001 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/19/2001 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/12/2001 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/02/2000 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/08/1998 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/30/1997 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/05/1996 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/25/1996 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/03/1995 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/04/1993 | SUPPL-27 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/07/1990 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/27/1989 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/13/1989 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/08/1988 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/29/1987 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 01/27/1988 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 07/08/1986 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/06/1986 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/13/1982 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/02/1982 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/02/1982 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/29/1980 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/04/1980 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/02/1979 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 02/23/1977 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 02/23/1977 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 02/23/1977 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/23/1977 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/28/1977 | SUPPL-3 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/08/2022 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017100s048lbl.pdf | |
| 06/06/2018 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017100s045lbl.pdf | |
| 05/04/2017 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017100s044lbl.pdf |