Details for New Drug Application (NDA): 214178
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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 214178
Tradename: | AMANTADINE HYDROCHLORIDE |
Applicant: | Elysium |
Ingredient: | amantadine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 214178
Mechanism of Action | M2 Protein Inhibitors |
Medical Subject Heading (MeSH) Categories for 214178
Suppliers and Packaging for NDA: 214178
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMANTADINE HYDROCHLORIDE | amantadine hydrochloride | SYRUP;ORAL | 214178 | ANDA | Patrin Pharma, Inc. | 39328-530 | 39328-530-16 | 473 mL in 1 BOTTLE, PLASTIC (39328-530-16) |
AMANTADINE HYDROCHLORIDE | amantadine hydrochloride | SYRUP;ORAL | 214178 | ANDA | Patrin Pharma, Inc. | 39328-530 | 39328-530-99 | 10 TRAY in 1 CASE (39328-530-99) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (39328-530-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 50MG/5ML | ||||
Approval Date: | Aug 20, 2021 | TE: | AA | RLD: | No |
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