Drugs@FDA: FDA-Approved Drugs
Company: ABBVIE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FML FORTE | FLUOROMETHOLONE | 0.25% | 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 |
---|---|---|---|---|---|---|---|
04/23/1986 | 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-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019216s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019216Orig1s025ltr.pdf | |
01/10/2006 | SUPPL-22 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019216s021s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019216s021s022ltr.pdf | |
01/10/2006 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019216s021s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019216s021s022ltr.pdf | |
09/04/2002 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/12/2002 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/04/2001 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/28/2001 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/12/2001 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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10/02/2000 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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09/14/1998 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/09/1997 | SUPPL-13 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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05/08/1998 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/05/1996 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/22/1994 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/03/1995 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/20/1993 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/21/1992 | SUPPL-7 | Labeling |
Label is not available on this site. |
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02/27/1990 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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10/13/1989 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/17/1989 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/18/1990 | SUPPL-3 | Labeling |
Label is not available on this site. |
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08/28/1986 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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11/05/1986 | 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 |
---|---|---|---|---|---|
02/12/2013 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019216s025lbl.pdf | |
01/10/2006 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019216s021s022lbl.pdf | |
01/10/2006 | SUPPL-21 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019216s021s022lbl.pdf |