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PARASAL

NDA

AMINOSALICYLIC ACID | N006811 | PANRAY CORP SUB ORMONT DRUG AND CHEMICAL CO INC

4 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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Rowell Laboratories FDA-1984-P-0032 Rowell Laboratories filed a citizen petition requesting that the FDA allow 5-aminosalicylic acid suppositories to be approved through the ANDA pathway, which would enable the company to market a generic version of this medication used to treat inflammatory bowel conditions.	Other	2014-12-29	Denied	Rowell Laboratories

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Products (4)

Sort:

#001 — 500MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 1GM

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

#006 — 500MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

#011 — 1GM

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982