Details for New Drug Application (NDA): 209171
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The generic ingredient in AMANTADINE HYDROCHLORIDE is amantadine hydrochloride. There are seven drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the amantadine hydrochloride profile page.
Summary for 209171
Tradename: | AMANTADINE HYDROCHLORIDE |
Applicant: | Heritage Pharma |
Ingredient: | amantadine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209171
Mechanism of Action | M2 Protein Inhibitors |
Medical Subject Heading (MeSH) Categories for 209171
Suppliers and Packaging for NDA: 209171
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMANTADINE HYDROCHLORIDE | amantadine hydrochloride | CAPSULE;ORAL | 209171 | ANDA | NCS HealthCare of KY, Inc dba Vangard Labs | 0615-8263 | 0615-8263-39 | 30 CAPSULE in 1 BLISTER PACK (0615-8263-39) |
AMANTADINE HYDROCHLORIDE | amantadine hydrochloride | CAPSULE;ORAL | 209171 | ANDA | Major Pharmaceuticals | 0904-7042 | 0904-7042-06 | 50 BLISTER PACK in 1 CARTON (0904-7042-06) / 1 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
Approval Date: | Jun 12, 2017 | TE: | AB | RLD: | No |
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