Details for New Drug Application (NDA): 019732
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The generic ingredient in LUPRON DEPOT 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 019732
| Tradename: | LUPRON DEPOT |
| Applicant: | Abbvie Endocrine Inc |
| Ingredient: | leuprolide acetate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 019732
Suppliers and Packaging for NDA: 019732
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 019732 | NDA | AbbVie Inc. | 0074-3642 | 0074-3642-03 | 1 KIT in 1 CARTON (0074-3642-03) * 1 mL in 1 SYRINGE (0074-9907-01) * 1 SWAB in 1 PACKET (0074-0009-01) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET |
| LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 019732 | NDA | AbbVie Inc. | 0074-3642 | 0074-3642-55 | 1 KIT in 1 CELLO PACK (0074-3642-55) * 1 mL in 1 SYRINGE (0074-9907-01) * 1 SWAB in 1 PACKET (0074-0009-01) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 7.5MG | ||||
| Approval Date: | Jan 26, 1989 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 019732
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abbvie Endocrine Inc | LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 019732-001 | Jan 26, 1989 | ⤷ Start Trial | ⤷ Start Trial |
| Abbvie Endocrine Inc | LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 019732-001 | Jan 26, 1989 | ⤷ Start Trial | ⤷ Start Trial |
| Abbvie Endocrine Inc | LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 019732-001 | Jan 26, 1989 | ⤷ Start Trial | ⤷ Start Trial |
| Abbvie Endocrine Inc | LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 019732-001 | Jan 26, 1989 | ⤷ Start Trial | ⤷ Start Trial |
| Abbvie Endocrine Inc | LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 019732-001 | Jan 26, 1989 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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