Details for New Drug Application (NDA): 214580
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NDA 214580 describes AMANTADINE HYDROCHLORIDE, which is a drug marketed by Zydus, Actavis Elizabeth, Alembic, Bionpharma, Chartwell Molecular, Heritage Pharma, Humanwell Puracap, Invagen Pharms, Rising, Rubicon, Sandoz, Strides Pharma, Upsher Smith Labs, Watson Labs, Watson Labs Inc, Zydus Pharms, Aurobindo Pharma Usa, Chartwell Rx, Cmp Pharma Inc, Elysium, Endo Operations, G And W Labs Inc, Pharm Assoc, Teva Pharms, Xttrium Labs Inc, Adaptis, Athem, Jubilant Generics, and Zhejiang Jutai Pharm, and is included in thirty-six NDAs. It is available from thirty-one suppliers. Additional details are available on the AMANTADINE HYDROCHLORIDE profile page.
The generic ingredient in AMANTADINE HYDROCHLORIDE is amantadine hydrochloride. There are seven drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the amantadine hydrochloride profile page.
The generic ingredient in AMANTADINE HYDROCHLORIDE is amantadine hydrochloride. There are seven drug master file entries for this compound. Thirty-two 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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