Details for New Drug Application (NDA): 213641
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NDA 213641 describes TERIPARATIDE, which is a drug marketed by Almaject, Amphastar Pharms Inc, Apotex, and Teva Pharms Usa, and is included in four NDAs. It is available from four suppliers. Additional details are available on the TERIPARATIDE profile page.
The generic ingredient in TERIPARATIDE is teriparatide. There are four drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the teriparatide profile page.
The generic ingredient in TERIPARATIDE is teriparatide. There are four drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the teriparatide profile page.
Summary for 213641
| Tradename: | TERIPARATIDE |
| Applicant: | Amphastar Pharms Inc |
| Ingredient: | teriparatide |
| Patents: | 0 |
Suppliers and Packaging for NDA: 213641
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TERIPARATIDE | teriparatide | SOLUTION;SUBCUTANEOUS | 213641 | ANDA | Amphastar Pharmaceuticals, Inc. | 0548-2311 | 0548-2311-00 | 1 SYRINGE in 1 CARTON (0548-2311-00) / 2.24 mL in 1 SYRINGE |
| TERIPARATIDE | teriparatide | SOLUTION;SUBCUTANEOUS | 213641 | ANDA | BluePoint Laboratories | 68001-693 | 68001-693-76 | 1 SYRINGE in 1 CARTON (68001-693-76) / 2.24 mL in 1 SYRINGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | 0.56MG/2.24ML (0.25MG/ML) | ||||
| Approval Date: | Dec 12, 2025 | TE: | AP | RLD: | No | ||||
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