Details for New Drug Application (NDA): 019010
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The generic ingredient in LUPRON is leuprolide acetate. There is one drug master file entry for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.
Summary for 019010
| Tradename: | LUPRON |
| Applicant: | Abbvie Endocrine Inc |
| Ingredient: | leuprolide acetate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 019010
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | 14MG/2.8ML (1MG/0.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Apr 9, 1985 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 019010
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abbvie Endocrine Inc | LUPRON | leuprolide acetate | SOLUTION;SUBCUTANEOUS | 019010-001 | Apr 9, 1985 | 4,005,063 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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