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Details for New Drug Application (NDA): 021318
NDA 021318 describes FORTEO, which is a drug marketed by Lilly and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the FORTEO profile page.
The generic ingredient in FORTEO is teriparatide recombinant human. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the teriparatide recombinant human profile page.
The generic ingredient in FORTEO is teriparatide recombinant human. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the teriparatide recombinant human profile page.
Summary for 021318
| Tradename: | FORTEO |
| Applicant: | Lilly |
| Ingredient: | teriparatide recombinant human |
| Patents: | 7 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 021318
| Ingredient-type | Parathyroid Hormone |
Suppliers and Packaging for NDA: 021318
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FORTEO | teriparatide recombinant human | INJECTABLE;SUBCUTANEOUS | 021318 | NDA | Eli Lilly and Company | 0002-8400 | N | 0002-8400-01 |
| FORTEO | teriparatide recombinant human | INJECTABLE;SUBCUTANEOUS | 021318 | NDA | Eli Lilly and Company | 0002-8400 | N | 0002-8400-99 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 0.75MG/3ML (0.25MG/ML) | ||||
| Approval Date: | Nov 26, 2002 | TE: | RLD: | No | |||||
| Patent: | ➤ Try a Free Trial | Patent Expiration: | Dec 8, 2018 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | FORTEO IS INDICATED FOR THE TREATMENT OF POST MENOPAUSAL WOMEN WITH OSTEOPOROSIS WHO ARE AT HIGH RISK FOR FRACTURE | ||||||||
| Patent: | ➤ Try a Free Trial | Patent Expiration: | Aug 19, 2019 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | FORTEO IS INDICATED FOR THE TREATMENT OF POST MENOPAUSAL WOMEN WITH OSTEOPOROSIS WHO ARE AT HIGH RISK FOR FRACTURE | ||||||||
| Patent: | ➤ Try a Free Trial | Patent Expiration: | Dec 8, 2018 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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