SYMMETREL® (Amantadine Hydrochloride USP) Tablets and Syrup
018101s016lbl.pdf
Draft Guidance on Amantadine Hydrochloride
Form/Route: Tablet/Oral. Recommended studies: 2 studies. 1. Type of study: Fasting. Design: Single-dose two-way crossover in-vivo. Strength: 100 mg.
Amantadine HCl tab RC
Draft Guidance on Amantadine Hydrochloride Active Ingredient
Draft Guidance on Amantadine Hydrochloride. Recommended Sept 2015 Capsule; oral. Recommended Studies: Two studies ... Strength: 100 mg.
Amamtadine Hydrochloride Oral Capsule RV
Safety Data Sheet Amantadine Hydrochloride Capsules USP
Each Amantadine Hydrochloride Capsules intended for oral administration contains older the daily dosage of amantadine hydrochloride capsules is 100 mg.
SDS ALEMP AMANTADINE HCL CAP MG BT
SYMMETREL® (Amantadine Hydrochloride USP) Tablets and Syrup
018101s015lbl.pdf
209410Orig1s000
12-Dec-2017 Approved GOCOVRI (amantadine) extended release capsules ... Release Tablets 320 mg Compared to 320 mg Amantadine HCl Oral Solution.
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NEW ZEALAND DATA SHEET
Each capsule contains amantadine hydrochloride 100 mg. Among paediatric patients Symmetrel is indicated only in children aged 5 years and above.
symmetrelcap
209410Orig1s000
31-Mar-2017 Dosage Form and Strength Extended Release Oral Tablets. 160 mg ... Initial dose of OSMOLEX™ ER tablet is 160 mg (amantadine HCl) once.
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Amantadine hydrochloride Oral Extended Release Tablet
Draft Guidance on Amantadine Hydrochloride. Recommended Sept 2019 Additional strengths: Bioequivalence of EQ 129 mg Base and EQ 193 mg Base to the.
PSG
Amantadine hydrochloride
Draft Guidance on Amantadine Hydrochloride Extended release capsule; oral ... Waiver request of in vivo testing: EQ 68.5 mg base based on (i) acceptable ...
Amantadine Hydrochloride Oral Extended Release Capsule NDA RC