Details for New Drug Application (NDA): 204327
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The generic ingredient in PARICALCITOL is paricalcitol. There are ten drug master file entries for this compound. Twelve 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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