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NEFAZODONE HYDROCHLORIDE

ANDA

NEFAZODONE HYDROCHLORIDE | A076196 | ROXANE LABORATORIES INC

5 strengths0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition From Wiley Rein LLP FDA-2014-P-0462 · 4 docket documents Wiley Rein LLP filed a citizen petition on April 14, 2014, under Section 505(j)(2)(c) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine that Amantadine Hydrochloride Tablets, 200 mg, is suitable for consideration in an ANDA, with the 100 mg tablet product (ANDA No. 076196	Other	2014-04-21	Withdrawn	Wiley Rein LLP

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

API Supply Chain1 active DMF1 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

TAPI NL BVNEFAZODONE HYDROCHLORIDE USP

DMF 142791999

SIGNA SA DE CVInactiveNEFAZODONE HYDROCHLORIDE

DMF 163872003

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.