Details for New Drug Application (NDA): 205917
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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 205917
Tradename: | PARICALCITOL |
Applicant: | Hikma Pharms |
Ingredient: | paricalcitol |
Patents: | 0 |
Suppliers and Packaging for NDA: 205917
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PARICALCITOL | paricalcitol | SOLUTION;INTRAVENOUS | 205917 | NDA | West-Ward Pharmaceuticals Corp | 0143-9596 | 0143-9596-25 | 25 VIAL, MULTI-DOSE in 1 CARTON (0143-9596-25) / 2 mL in 1 VIAL, MULTI-DOSE (0143-9596-01) |
PARICALCITOL | paricalcitol | SOLUTION;INTRAVENOUS | 205917 | NDA | West-Ward Pharmaceuticals Corp | 0143-9624 | 0143-9624-25 | 25 VIAL, SINGLE-DOSE in 1 CARTON (0143-9624-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0143-9624-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 0.002MG/ML (0.002MG/ML) | ||||
Approval Date: | Nov 18, 2014 | 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: | Nov 18, 2014 | 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: | Nov 18, 2014 | TE: | AP | RLD: | No |
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