Details for New Drug Application (NDA): 205982
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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 205982
| Tradename: | PARICALCITOL |
| Applicant: | Eugia Pharma |
| Ingredient: | paricalcitol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 205982
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PARICALCITOL | paricalcitol | SOLUTION;INTRAVENOUS | 205982 | ANDA | Eugia US LLC | 55150-212 | 55150-212-01 | 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-212-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| PARICALCITOL | paricalcitol | SOLUTION;INTRAVENOUS | 205982 | ANDA | Eugia US LLC | 55150-213 | 55150-213-01 | 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-213-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 0.002MG/ML (0.002MG/ML) | ||||
| Approval Date: | Oct 9, 2018 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 0.005MG/ML (0.005MG/ML) | ||||
| Approval Date: | Oct 9, 2018 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 0.01MG/2ML (0.005MG/ML) | ||||
| Approval Date: | Oct 9, 2018 | TE: | RLD: | No | |||||
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