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Details for New Drug Application (NDA): 020517
The generic ingredient in LUPRON DEPOT is leuprolide acetate. There are twenty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.
Summary for 020517
Tradename: | LUPRON DEPOT |
Applicant: | Abbvie Endocrine Inc |
Ingredient: | leuprolide acetate |
Patents: | 3 |
Therapeutic Class: | Hormonal Agents, Suppressant (Pituitary) |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 020517
Suppliers and Packaging for NDA: 020517
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 020517 | NDA | AbbVie Inc. | 0074-3346 | N | 0074-3346-03 |
LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 020517 | NDA | AbbVie Inc. | 0074-3473 | N | 0074-3473-03 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 22.5MG/VIAL | ||||
Approval Date: | Dec 22, 1995 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 30MG/VIAL | ||||
Approval Date: | May 30, 1997 | TE: | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 45MG/VIAL | ||||
Approval Date: | Jun 17, 2011 | TE: | RLD: | Yes | |||||
Patent: | ➤ Try a Free Trial | Patent Expiration: | Jan 13, 2019 | Product Flag? | Y | Substance Flag? | Delist Request? |
Expired US Patents for NDA 020517
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Abbvie Endocrine Inc | LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 020517-001 | Dec 22, 1995 | ➤ Try a Free Trial | ➤ Try a Free Trial |
Abbvie Endocrine Inc | LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 020517-001 | Dec 22, 1995 | ➤ Try a Free Trial | ➤ Try a Free Trial |
Abbvie Endocrine Inc | LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 020517-002 | May 30, 1997 | ➤ Try a Free Trial | ➤ Try a Free Trial |
Abbvie Endocrine Inc | LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 020517-001 | Dec 22, 1995 | ➤ Try a Free Trial | ➤ Try a Free Trial |
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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