Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070886
Company: AUROLIFE PHARMA LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.2MG TABLET;ORAL Discontinued None No No
CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.1MG TABLET;ORAL Discontinued None No No
CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.3MG 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
08/31/1988 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
03/02/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/25/1998 SUPPL-5 Labeling

Label is not available on this site.

02/01/1995 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/04/1992 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

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