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AMANTADINE HYDROCHLORIDE

ANDA

AMANTADINE HYDROCHLORIDE | A071293 | SANDOZ INC

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Axinn, Veltrop & Harkrider LLP FDA-2017-P-6027 · 6 docket documents Chad A. Landmon, submitting on behalf of a petitioner through the law firm Axinn, Veltrop & Harkrider LLP, filed an ANDA suitability petition under Section 505(j)(2)(C) requesting that the FDA declare Amantadine Hydrochloride Capsules, 200 mg, suitable for submission in an Abbreviated New Drug Appli	Other	2017-10-04	Granted	Axinn, Veltrop & Harkrider LLP
Citizen Petition From Wiley Rein LLP FDA-2014-P-0461 · 3 docket documents Wiley Rein LLP filed this citizen petition pursuant to Section 505(j)(2)(c) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Amantadine Hydrochloride Capsules, 200 mg, suitable for consideration in an Abbreviated New Drug Application, with the reference listed drug being am	Other	2014-04-21	Withdrawn	Wiley Rein LLP

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

API Supply Chain5 active DMFs1 inactive

5 active API suppliers hold Drug Master Files for this ingredient.

MOEHS IBERICA SLAMANTADINE HYDROCHLORIDE

DMF 69241987

OLPHA ASAMANTADINE HYDROCHLORIDE

DMF 235282010

ZHEJIANG APELOA KANGYU PHARMACEUTICAL CO LTDAMANTADINE HYDROCHLORIDE USP

DMF 251512011

ANONIMA MATERIE SINTETICHE AND AFFINI (AMSA) SPAAMANTADINE HYDROCHLORIDE

DMF 294862015

ALEMBIC PHARMACEUTICALS LTDAMANTADINE HYDROCHLORIDE USP

DMF 415172025

NORTHEAST GENERAL PHARMACEUTICAL FACTORYInactiveAMANTADINE HYDROCHLORIDE

DMF 96651992

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

Products (1)

#001 — 100MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Feb 18, 1987

No patent or exclusivity listings for this strength.