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Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.

ROSUVASTATIN ZINC

NDA

Tentative Approval

ROSUVASTATIN ZINC | N202172 | WATSON LABS INC

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
AstraZeneca UK Limited et al v. Watson Pharmaceuticals Inc. et al 1:2010cv00915 1 patentrosuvastatin calcium	D. Del.	2010-10-26	Terminated 2013-03-26	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Feb 16, 2016	ORIG -1	View Letter (PDF)
Aug 8, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 5MG

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TABLET; ORAL | TA Date: 2016-02-12 00:00:00

No patent or exclusivity listings for this strength.

#002 — 10MG

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TABLET; ORAL | TA Date: 2016-02-12 00:00:00

#003 — 20MG

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TABLET; ORAL | TA Date: 2016-02-12 00:00:00

#004 — 40MG

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TABLET; ORAL | TA Date: 2016-02-12 00:00:00