Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202984
Company: ANCHEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.1MG TABLET, EXTENDED RELEASE;ORAL Prescription AB1 No No
CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.2MG TABLET, EXTENDED RELEASE;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
09/30/2013 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202984Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/29/2016 SUPPL-6 Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Patient Package Insert

Label is not available on this site.

03/29/2016 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

CLONIDINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; 0.1MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.1MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 203320 ACTAVIS ELIZABETH
CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.1MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 209686 AJANTA PHARMA LTD
CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.1MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 210052 AMNEAL PHARMS NY
CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.1MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 202984 ANCHEN PHARMS
CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.1MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 210338 JUBILANT GENERICS
CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.1MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 209285 LUPIN LTD
CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.1MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 210680 MAYNE PHARMA INC
CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.1MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 209675 NOVAST LABS
CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.1MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 209757 XIAMEN LP PHARM CO
KAPVAY CLONIDINE HYDROCHLORIDE 0.1MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB1 022331 CONCORDIA PHARMS INC

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