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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016968
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
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