Application 125511
- Type
- BLA
- Sponsor
- NPS PHARMS INC
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 125511 | Natpara | parathyroid hormone | 351(a) | Rx | 2026-06-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | NATPARA | PARATHYROID HORMONE | INJECTABLE;INJECTION | 25MCG | Yes | No |
| 002 | NATPARA | PARATHYROID HORMONE | INJECTABLE;INJECTION | 50MCG | Yes | No |
| 003 | NATPARA | PARATHYROID HORMONE | INJECTABLE;INJECTION | 75MCG | Yes | No |
| 004 | NATPARA | PARATHYROID HORMONE | INJECTABLE;INJECTION | 100MCG | Yes | No |
NDC Listings For This Application#
NDC listings for this application page 1 of 1 ยท 16 matching rows.
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 68875-0202 | NATPARA (parathyroid hormone) | PARATHYROID HORMONE | Takeda Pharmaceuticals America, Inc. | BLA | Current |
| 68875-0202 | NATPARA (parathyroid hormone) | PARATHYROID HORMONE | Shire-NPS Pharmaceuticals, Inc. | BLA | Current |
| 68875-0202 | NATPARA (parathyroid hormone) | PARATHYROID HORMONE | Shire-NPS Pharmaceuticals, Inc. | BLA | Current |
| 68875-0202 | NATPARA (parathyroid hormone) | PARATHYROID HORMONE | Shire-NPS Pharmaceuticals, Inc. | BLA | Current |
| 68875-0203 | NATPARA (parathyroid hormone) | PARATHYROID HORMONE | Takeda Pharmaceuticals America, Inc. | BLA | Current |
| 68875-0203 | NATPARA (parathyroid hormone) | PARATHYROID HORMONE | Shire-NPS Pharmaceuticals, Inc. | BLA | Current |
| 68875-0203 | NATPARA (parathyroid hormone) | PARATHYROID HORMONE | Shire-NPS Pharmaceuticals, Inc. | BLA | Current |
| 68875-0203 | NATPARA (parathyroid hormone) | PARATHYROID HORMONE | Shire-NPS Pharmaceuticals, Inc. | BLA | Current |
| 68875-0204 | NATPARA (parathyroid hormone) | PARATHYROID HORMONE | Takeda Pharmaceuticals America, Inc. | BLA | Current |
| 68875-0204 | NATPARA (parathyroid hormone) | PARATHYROID HORMONE | Shire-NPS Pharmaceuticals, Inc. | BLA | Current |
| 68875-0204 | NATPARA (parathyroid hormone) | PARATHYROID HORMONE | Shire-NPS Pharmaceuticals, Inc. | BLA | Current |
| 68875-0204 | NATPARA (parathyroid hormone) | PARATHYROID HORMONE | Shire-NPS Pharmaceuticals, Inc. | BLA | Current |
| 68875-0205 | NATPARA (parathyroid hormone) | PARATHYROID HORMONE | Takeda Pharmaceuticals America, Inc. | BLA | Current |
| 68875-0205 | NATPARA (parathyroid hormone) | PARATHYROID HORMONE | Shire-NPS Pharmaceuticals, Inc. | BLA | Current |
| 68875-0205 | NATPARA (parathyroid hormone) | PARATHYROID HORMONE | Shire-NPS Pharmaceuticals, Inc. | BLA | Current |
| 68875-0205 | NATPARA (parathyroid hormone) | PARATHYROID HORMONE | Shire-NPS Pharmaceuticals, Inc. | BLA | Current |