Details for New Drug Application (NDA): 212797
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NDA 212797 describes PRAMIPEXOLE DIHYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Alembic, Dr Reddys, Endo Operations, Macleods Pharms Ltd, Novast Labs, Sandoz, Xiamen Lp Pharm Co, Zydus Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Glenmark Pharms Ltd, Heritage Pharma Avet, Natco, Natco Pharma, Nostrum Labs Inc, Rising, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Inc, Torrent Pharms, Unichem, Zennova, and Zydus Pharms Usa Inc, and is included in thirty NDAs. It is available from twenty-four suppliers. Additional details are available on the PRAMIPEXOLE DIHYDROCHLORIDE profile page.
The generic ingredient in PRAMIPEXOLE DIHYDROCHLORIDE is pramipexole dihydrochloride. There are twenty-five drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the pramipexole dihydrochloride profile page.
The generic ingredient in PRAMIPEXOLE DIHYDROCHLORIDE is pramipexole dihydrochloride. There are twenty-five drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the pramipexole dihydrochloride profile page.
Summary for 212797
| Tradename: | PRAMIPEXOLE DIHYDROCHLORIDE |
| Applicant: | Xiamen Lp Pharm Co |
| Ingredient: | pramipexole dihydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 212797
| Mechanism of Action | Dopamine Agonists |
Suppliers and Packaging for NDA: 212797
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PRAMIPEXOLE DIHYDROCHLORIDE | pramipexole dihydrochloride | TABLET, EXTENDED RELEASE;ORAL | 212797 | ANDA | Vitruvias Therapeutics, Inc. | 69680-145 | 69680-145-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (69680-145-30) |
| PRAMIPEXOLE DIHYDROCHLORIDE | pramipexole dihydrochloride | TABLET, EXTENDED RELEASE;ORAL | 212797 | ANDA | Vitruvias Therapeutics, Inc. | 69680-146 | 69680-146-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (69680-146-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 0.375MG | ||||
| Approval Date: | Jun 11, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 0.75MG | ||||
| Approval Date: | Jun 11, 2021 | TE: | AB | RLD: | No | ||||
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