Details for New Drug Application (NDA): 212407
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NDA 212407 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 212407
| Tradename: | AMANTADINE HYDROCHLORIDE |
| Applicant: | Adaptis |
| Ingredient: | amantadine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 212407
| Mechanism of Action | M2 Protein Inhibitors |
Medical Subject Heading (MeSH) Categories for 212407
Suppliers and Packaging for NDA: 212407
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMANTADINE HYDROCHLORIDE | amantadine hydrochloride | TABLET;ORAL | 212407 | ANDA | Edenbridge Pharmaceuticals LLC. | 42799-118 | 42799-118-01 | 100 TABLET in 1 BOTTLE (42799-118-01) |
| AMANTADINE HYDROCHLORIDE | amantadine hydrochloride | TABLET;ORAL | 212407 | ANDA | Edenbridge Pharmaceuticals LLC. | 42799-118 | 42799-118-02 | 500 TABLET in 1 BOTTLE (42799-118-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | May 27, 2022 | TE: | RLD: | No | |||||
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