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AMTURNIDE (ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE) | LOERadar

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AMTURNIDE

NDA

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE | N200045 | NOVARTIS PHARMACEUTICALS CORP

5 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

14 letters from Drugs@FDA

Date	Submission	Document
Nov 8, 2016	SUPPL -20	View Letter (PDF)
Dec 23, 2015	SUPPL -17	View Letter (PDF)
Apr 1, 2015	SUPPL -16	View Letter (PDF)
Nov 6, 2013	SUPPL -14	View Letter (PDF)
Oct 2, 2012	SUPPL -13	View Letter (PDF)
Oct 2, 2012	SUPPL -11	View Letter (PDF)
Apr 18, 2012	SUPPL -12	View Letter (PDF)
Feb 17, 2012	SUPPL -6	View Letter (PDF)
Feb 6, 2012	SUPPL -10	View Letter (PDF)
Jan 30, 2012	SUPPL -7	View Letter (PDF)
Nov 7, 2011	SUPPL -9	View Letter (PDF)
Oct 14, 2011	SUPPL -4	View Letter (PDF)
Oct 14, 2011	SUPPL -3	View Letter (PDF)
Dec 28, 2010	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — EQ 150MG BASE;EQ 5MG BASE;12.5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 21, 2010

No patent or exclusivity listings for this strength.

#002 — EQ 300MG BASE;EQ 5MG BASE;12.5MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 21, 2010

#003 — EQ 300MG BASE;EQ 5MG BASE;25MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 21, 2010

#004 — EQ 300MG BASE;EQ 10MG BASE;12.5MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 21, 2010

#005 — EQ 300MG BASE;EQ 10MG BASE;25MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 21, 2010