Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075150
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLONAZEPAM CLONAZEPAM 0.5MG TABLET;ORAL Discontinued None No No
CLONAZEPAM CLONAZEPAM 1MG TABLET;ORAL Discontinued None No No
CLONAZEPAM CLONAZEPAM 2MG TABLET;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/05/1998 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75150LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75150_Clonazepam.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/25/2012 SUPPL-15 Labeling-Package Insert, REMS-Modified

Label is not available on this site.

04/08/2011 SUPPL-13 Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide, REMS-Proposal

Label is not available on this site.

10/15/2009 SUPPL-11 Labeling

Label is not available on this site.

11/24/2003 SUPPL-3 Labeling

Label is not available on this site.

02/28/2001 SUPPL-1 Labeling

Label is not available on this site.

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