Details for New Drug Application (NDA): 020819
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NDA 020819 describes ZEMPLAR, which is a drug marketed by Abbvie and is included in two NDAs. It is available from one supplier. Additional details are available on the ZEMPLAR profile page.
The generic ingredient in ZEMPLAR 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.
The generic ingredient in ZEMPLAR 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 020819
| Tradename: | ZEMPLAR |
| Applicant: | Abbvie |
| Ingredient: | paricalcitol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 020819
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZEMPLAR | paricalcitol | SOLUTION;INTRAVENOUS | 020819 | NDA | AbbVie Inc. | 0074-1658 | 0074-1658-01 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0074-1658-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ZEMPLAR | paricalcitol | SOLUTION;INTRAVENOUS | 020819 | NDA | AbbVie Inc. | 0074-1658 | 0074-1658-05 | 25 VIAL, MULTI-DOSE in 1 TRAY (0074-1658-05) / 2 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 0.005MG/ML (0.005MG/ML) | ||||
| Approval Date: | Apr 17, 1998 | TE: | AP | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 0.002MG/ML (0.002MG/ML) | ||||
| Approval Date: | Feb 1, 2000 | TE: | AP | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 0.01MG/2ML (0.005MG/ML) | ||||
| Approval Date: | Feb 1, 2000 | TE: | AP | RLD: | Yes | ||||
Expired US Patents for NDA 020819
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abbvie | ZEMPLAR | paricalcitol | SOLUTION;INTRAVENOUS | 020819-001 | Apr 17, 1998 | ⤷ Subscribe | ⤷ Subscribe |
| Abbvie | ZEMPLAR | paricalcitol | SOLUTION;INTRAVENOUS | 020819-002 | Feb 1, 2000 | ⤷ Subscribe | ⤷ Subscribe |
| Abbvie | ZEMPLAR | paricalcitol | SOLUTION;INTRAVENOUS | 020819-001 | Apr 17, 1998 | ⤷ Subscribe | ⤷ Subscribe |
| Abbvie | ZEMPLAR | paricalcitol | SOLUTION;INTRAVENOUS | 020819-002 | Feb 1, 2000 | ⤷ Subscribe | ⤷ Subscribe |
| Abbvie | ZEMPLAR | paricalcitol | SOLUTION;INTRAVENOUS | 020819-001 | Apr 17, 1998 | ⤷ Subscribe | ⤷ Subscribe |
| Abbvie | ZEMPLAR | paricalcitol | SOLUTION;INTRAVENOUS | 020819-003 | Feb 1, 2000 | ⤷ Subscribe | ⤷ Subscribe |
| Abbvie | ZEMPLAR | paricalcitol | SOLUTION;INTRAVENOUS | 020819-001 | Apr 17, 1998 | ⤷ Subscribe | ⤷ Subscribe |
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