Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 209410

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OSMOLEX ER (AMANTADINE HYDROCHLORIDE)
EQ 129MG BASE Marketing Status: Prescription

Active Ingredient: AMANTADINE HYDROCHLORIDE
Proprietary Name: OSMOLEX ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 129MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N209410
Product Number: 001
Approval Date: Feb 16, 2018
Applicant Holder Full Name: OSMOTICA PHARMACEUTICAL
Marketing Status:  Prescription
Patent and Exclusivity Information

OSMOLEX ER (AMANTADINE HYDROCHLORIDE)
EQ 193MG BASE Marketing Status: Prescription

Active Ingredient: AMANTADINE HYDROCHLORIDE
Proprietary Name: OSMOLEX ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 193MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N209410
Product Number: 002
Approval Date: Feb 16, 2018
Applicant Holder Full Name: OSMOTICA PHARMACEUTICAL
Marketing Status:  Prescription
Patent and Exclusivity Information

OSMOLEX ER (AMANTADINE HYDROCHLORIDE)
EQ 258MG BASE Marketing Status: Prescription

Active Ingredient: AMANTADINE HYDROCHLORIDE
Proprietary Name: OSMOLEX ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 258MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209410
Product Number: 003
Approval Date: Feb 16, 2018
Applicant Holder Full Name: OSMOTICA PHARMACEUTICAL
Marketing Status:  Prescription
Patent and Exclusivity Information

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