Details for New Drug Application (NDA): 021318
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The generic ingredient in FORTEO is teriparatide. There are four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the teriparatide profile page.
Summary for 021318
Tradename: | FORTEO |
Applicant: | Lilly |
Ingredient: | teriparatide |
Patents: | 1 |
Suppliers and Packaging for NDA: 021318
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FORTEO | teriparatide | SOLUTION;SUBCUTANEOUS | 021318 | NDA | Eli Lilly and Company | 0002-8400 | 0002-8400-01 | 1 SYRINGE in 1 CARTON (0002-8400-01) / 2.24 mL in 1 SYRINGE |
FORTEO | teriparatide | SOLUTION;SUBCUTANEOUS | 021318 | NDA AUTHORIZED GENERIC | Prasco Laboratories | 66993-495 | 66993-495-28 | 1 SYRINGE in 1 CARTON (66993-495-28) / 2.24 mL in 1 SYRINGE |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | 0.75MG/3ML (0.25MG/ML) | ||||
Approval Date: | Nov 26, 2002 | TE: | RLD: | No | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 25, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | 0.6MG/2.4ML (0.25MG/ML) | ||||
Approval Date: | Jun 25, 2008 | TE: | AP | RLD: | Yes |
Expired US Patents for NDA 021318
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Lilly | FORTEO | teriparatide | SOLUTION;SUBCUTANEOUS | 021318-001 | Nov 26, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Lilly | FORTEO | teriparatide | SOLUTION;SUBCUTANEOUS | 021318-002 | Jun 25, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Lilly | FORTEO | teriparatide | SOLUTION;SUBCUTANEOUS | 021318-001 | Nov 26, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Lilly | FORTEO | teriparatide | SOLUTION;SUBCUTANEOUS | 021318-001 | Nov 26, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Lilly | FORTEO | teriparatide | SOLUTION;SUBCUTANEOUS | 021318-002 | Jun 25, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Lilly | FORTEO | teriparatide | SOLUTION;SUBCUTANEOUS | 021318-001 | Nov 26, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Lilly | FORTEO | teriparatide | SOLUTION;SUBCUTANEOUS | 021318-002 | Jun 25, 2008 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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