Drugs@FDA: FDA-Approved Drugs
Company: ABBVIE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FML | FLUOROMETHOLONE | 0.1% | 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 |
|---|---|---|---|---|---|---|---|
| 01/12/1972 | 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 |
|---|---|---|---|---|---|
| 02/12/2013 | SUPPL-63 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016851s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/016851Orig1s063ltr.pdf | |
| 03/19/2003 | SUPPL-59 | Labeling |
Label is not available on this site. |
||
| 07/18/2002 | SUPPL-57 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/12/2002 | SUPPL-56 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/04/2001 | SUPPL-55 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/24/2001 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/12/2001 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/02/2000 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/28/2001 | SUPPL-51 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16851s51lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16851s51ltr.pdf | |
| 06/30/1998 | SUPPL-50 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/01/1998 | SUPPL-49 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/18/1996 | SUPPL-48 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 12/05/1996 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/22/1994 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/03/1995 | SUPPL-45 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/20/1993 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/08/1993 | SUPPL-43 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 05/20/1992 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 04/27/1989 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/12/1989 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/01/1989 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/20/1992 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 07/18/1986 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/31/1984 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/14/1983 | SUPPL-33 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 08/13/1982 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/28/1982 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/28/1982 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/30/1980 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/27/1979 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/09/1979 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/14/1978 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 09/12/1978 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/14/1978 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 08/14/1978 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 08/14/1978 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 08/14/1978 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 08/14/1978 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 09/20/1978 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/20/1978 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 02/26/1975 | SUPPL-13 |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/12/2013 | SUPPL-63 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016851s063lbl.pdf | |
| 06/28/2001 | SUPPL-51 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16851s51lbl.pdf |
FML
SUSPENSION/DROPS;OPHTHALMIC; 0.1%
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FLUOROMETHOLONE | FLUOROMETHOLONE | 0.1% | SUSPENSION/DROPS;OPHTHALMIC | Prescription | No | AB | 216348 | AMNEAL |
| FML | FLUOROMETHOLONE | 0.1% | SUSPENSION/DROPS;OPHTHALMIC | Prescription | Yes | AB | 016851 | ABBVIE |