Details for New Drug Application (NDA): 078894
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NDA 078894 describes PRAMIPEXOLE DIHYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Alembic, Chartwell Rx, Dr Reddys, Macleods Pharms Ltd, Novast Labs, Ph Health, Xiamen Lp Pharm Co, Zydus Pharms, Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Heritage Pharma Avet, Natco, Natco Pharma, Pharmobedient, Rising, Sandoz, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Inc, Torrent Pharms, Unichem, and Zydus Pharms Usa Inc, and is included in thirty NDAs. It is available from twenty-two 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-two 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-two suppliers are listed for this compound. Additional details are available on the pramipexole dihydrochloride profile page.
Summary for 078894
| Tradename: | PRAMIPEXOLE DIHYDROCHLORIDE |
| Applicant: | Alembic |
| Ingredient: | pramipexole dihydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 078894
| Mechanism of Action | Dopamine Agonists |
Suppliers and Packaging for NDA: 078894
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PRAMIPEXOLE DIHYDROCHLORIDE | pramipexole dihydrochloride | TABLET;ORAL | 078894 | ANDA | Alembic Pharmaceuticals Limited | 46708-003 | 46708-003-90 | 90 TABLET in 1 BOTTLE (46708-003-90) |
| PRAMIPEXOLE DIHYDROCHLORIDE | pramipexole dihydrochloride | TABLET;ORAL | 078894 | ANDA | Alembic Pharmaceuticals Limited | 46708-004 | 46708-004-90 | 90 TABLET in 1 BOTTLE (46708-004-90) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 0.125MG | ||||
| Approval Date: | Oct 8, 2010 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 0.25MG | ||||
| Approval Date: | Oct 8, 2010 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
| Approval Date: | Oct 8, 2010 | TE: | RLD: | No | |||||
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