Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070317
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.3MG TABLET;ORAL Discontinued None No No
CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.1MG TABLET;ORAL Discontinued None No No
CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.2MG 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
06/09/1987 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/16/2013 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

02/05/1998 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/15/1997 SUPPL-8 Labeling

Label is not available on this site.

02/24/1995 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/01/1993 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/22/1991 SUPPL-4 Labeling

Label is not available on this site.

01/31/1990 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/29/1991 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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