Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 011366
Company: STRONGBRIDGE US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DARANIDE DICHLORPHENAMIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
KEVEYIS DICHLORPHENAMIDE 50MG TABLET;ORAL 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
07/22/1958 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/07/2015 SUPPL-30 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011366s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/011366Orig1s030ltr.pdf
12/19/2013 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

03/16/2012 SUPPL-28 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/011366s028ltr.pdf
10/24/1994 SUPPL-27 Labeling

Label is not available on this site.

06/13/1995 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

06/02/1989 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

02/12/1991 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

09/06/1985 SUPPL-23 Labeling

Label is not available on this site.

09/06/1985 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

08/06/1984 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

02/26/1982 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

11/05/1986 SUPPL-18 Labeling

Label is not available on this site.

12/18/1979 SUPPL-17 Labeling

Label is not available on this site.

12/20/1979 SUPPL-16 Labeling

Label is not available on this site.

07/28/1978 SUPPL-15 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
08/07/2015 SUPPL-30 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011366s030lbl.pdf

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