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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.

SYMMETREL

NDA

Tentative Approval

AMANTADINE HYDROCHLORIDE | N017118 | ENDO PHARMS

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
Osmotica Pharmaceutical US LLC et al v. Adamas Pharmaceuticals, Inc. et al 1:2018cv00278 14 patentsANDA 075060amantadine hydrochloride	D. Del.	2018-02-16	Terminated 2021-01-07	—

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

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.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jan 6, 2009	SUPPL -19	View Letter (PDF)
Sep 29, 2003	SUPPL -17	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 50MG/5ML

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SYRUP; ORAL | Approved: 1976-07-20 00:00:00

No patent or exclusivity listings for this strength.