Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071785
Company: CHARTWELL MOLECULES
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
04/05/1988 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
06/08/2017 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

10/05/2006 SUPPL-13 Labeling

Label is not available on this site.

09/18/2000 SUPPL-11 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

05/18/1998 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/18/1997 SUPPL-9 Labeling

Label is not available on this site.

11/13/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/26/1994 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/03/1990 SUPPL-6 Labeling

Label is not available on this site.

10/18/1989 SUPPL-5 Labeling

Label is not available on this site.

05/12/1988 SUPPL-2 Labeling

Label is not available on this site.

05/12/1988 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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