Drugs@FDA: FDA-Approved Drugs
Company: ALCON
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MIOSTAT | CARBACHOL | 0.01% | SOLUTION;INTRAOCULAR | 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 |
---|---|---|---|---|---|---|---|
09/28/1972 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/21/2016 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016968s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016968Orig1s029ltr.pdf | |
02/23/2015 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/10/2004 | SUPPL-22 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16968s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16968s022ltr.pdf | |
11/25/2002 | SUPPL-20 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16968slr020_Miostat_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16968slr020ltr.pdf | |
12/18/2001 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/18/1999 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
04/15/1999 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
05/02/1997 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/14/1997 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/26/1996 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/18/1995 | SUPPL-13 | Efficacy-New Indication |
Label is not available on this site. |
||
12/14/1989 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
08/13/1984 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
12/06/1983 | SUPPL-8 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
05/16/1983 | SUPPL-7 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
04/24/1980 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
04/24/1980 | SUPPL-5 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
06/12/1978 | SUPPL-4 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
06/12/1978 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
08/08/1978 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
01/21/2016 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016968s029lbl.pdf | |
11/10/2004 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16968s022lbl.pdf | |
11/25/2002 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16968slr020_Miostat_lbl.pdf |