Details for New Drug Application (NDA): 214580
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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 214580
Tradename: | AMANTADINE HYDROCHLORIDE |
Applicant: | Humanwell Puracap |
Ingredient: | amantadine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 214580
Mechanism of Action | M2 Protein Inhibitors |
Medical Subject Heading (MeSH) Categories for 214580
Suppliers and Packaging for NDA: 214580
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMANTADINE HYDROCHLORIDE | amantadine hydrochloride | CAPSULE;ORAL | 214580 | ANDA | EPIC PHARMA LLC | 42806-716 | 42806-716-05 | 500 CAPSULE in 1 BOTTLE (42806-716-05) |
AMANTADINE HYDROCHLORIDE | amantadine hydrochloride | CAPSULE;ORAL | 214580 | ANDA | EPIC PHARMA LLC | 42806-716 | 42806-716-11 | 10 CAPSULE in 1 BOTTLE (42806-716-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
Approval Date: | Dec 20, 2022 | TE: | AB | RLD: | No |
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