Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018677
Company: MYLAN SPECIALITY LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CESAMET NABILONE 1MG CAPSULE;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
12/26/1985 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Submission Classification Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/30/2015 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

12/05/2008 SUPPL-13 Manufacturing (CMC)-Formulation Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018677s013ltr.pdf
05/15/2006 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018677s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018677s011LTR.pdf
06/23/1989 SUPPL-6 Labeling

Label is not available on this site.

04/11/1989 SUPPL-5 Labeling

Label is not available on this site.

03/18/1988 SUPPL-4 Labeling

Label is not available on this site.

11/30/1987 SUPPL-3 Labeling

Label is not available on this site.

12/04/1986 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

12/04/1986 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Submission Classification or
Approval
Type
Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/15/2006 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018677s011lbl.pdf

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