Suppliers and packages for generic ingredient: AMANTADINE HYDROCHLORIDE
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AMANTADINE HYDROCHLORIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Supernus Pharms | GOCOVRI | amantadine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 208944 | NDA | Adamas Pharma, LLC | 70482-085-21 | 21 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-085-21) | 2017-08-24 |
| Supernus Pharms | GOCOVRI | amantadine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 208944 | NDA | Adamas Pharma, LLC | 70482-085-60 | 60 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-085-60) | 2017-08-24 |
| Supernus Pharms | GOCOVRI | amantadine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 208944 | NDA | Adamas Pharma, LLC | 70482-085-61 | 60 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-085-61) | 2017-08-24 |
| Supernus Pharms | GOCOVRI | amantadine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 208944 | NDA | Adamas Pharma, LLC | 70482-170-21 | 21 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-170-21) | 2017-08-24 |
| Supernus Pharms | GOCOVRI | amantadine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 208944 | NDA | Adamas Pharma, LLC | 70482-170-60 | 60 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-170-60) | 2017-08-24 |
| Supernus Pharms | GOCOVRI | amantadine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 208944 | NDA | Adamas Pharma, LLC | 70482-170-61 | 60 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-170-61) | 2017-08-24 |
| Alembic | AMANTADINE HYDROCHLORIDE | amantadine hydrochloride | CAPSULE;ORAL | 208966 | ANDA | Alembic Pharmaceuticals Limited | 46708-246-30 | 30 CAPSULE in 1 BOTTLE (46708-246-30) | 2017-06-22 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
