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. Twelve 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 |
Formulation / Manufacturing: | see details |
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: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 0.002MG/ML (0.002MG/ML) | ||||
Approval Date: | Oct 9, 2018 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 0.005MG/ML (0.005MG/ML) | ||||
Approval Date: | Oct 9, 2018 | TE: | AP | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 0.01MG/2ML (0.005MG/ML) | ||||
Approval Date: | Oct 9, 2018 | TE: | AP | RLD: | No |
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