Details for New Drug Application (NDA): 204327
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NDA 204327 describes PARICALCITOL, which is a drug marketed by Amneal Pharms, Aurobindo Pharma Ltd, Bionpharma, Chartwell Rx, Lotus Pharm Co Ltd, Marksans Pharma, Rising, Teva Pharms Usa, Accord Hlthcare, Amneal Pharms Co, Caplin, Epic Pharma Llc, Eugia Pharma, Hikma Pharms, Hospira, and Sandoz, and is included in seventeen NDAs. It is available from ten suppliers. Additional details are available on the PARICALCITOL profile page.
The generic ingredient in PARICALCITOL is paricalcitol. There are ten drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the paricalcitol profile page.
The generic ingredient in PARICALCITOL is paricalcitol. There are ten drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the paricalcitol profile page.
Summary for 204327
| Tradename: | PARICALCITOL |
| Applicant: | Amneal Pharms |
| Ingredient: | paricalcitol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 204327
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PARICALCITOL | paricalcitol | CAPSULE;ORAL | 204327 | ANDA | Amneal Pharmaceuticals LLC | 65162-822 | 65162-822-03 | 30 CAPSULE in 1 BOTTLE (65162-822-03) |
| PARICALCITOL | paricalcitol | CAPSULE;ORAL | 204327 | ANDA | Amneal Pharmaceuticals LLC | 65162-822 | 65162-822-09 | 90 CAPSULE in 1 BOTTLE (65162-822-09) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 1MCG | ||||
| Approval Date: | Jan 13, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 2MCG | ||||
| Approval Date: | Jan 13, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 4MCG | ||||
| Approval Date: | Jan 13, 2016 | TE: | AB | RLD: | No | ||||
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