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FORTICAL

NDA

CALCITONIN SALMON RECOMBINANT | N021406 | UPSHER SMITH LABORATORIES LLC

1 strength0 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Jul 10, 2014	SUPPL -22	View Letter (PDF)
Jul 10, 2014	SUPPL -17	View Letter (PDF)
Aug 17, 2011	SUPPL -16	View Letter (PDF)
Jun 26, 2009	SUPPL -8	View Letter (PDF)
Feb 12, 2007	SUPPL -7	View Letter (PDF)
May 1, 2006	SUPPL -3	View Letter (PDF)
Aug 19, 2005	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▴

SPRAY, METERED;NASAL | Approved: Aug 12, 2005

No patent or exclusivity listings for this strength.