Details for New Drug Application (NDA): 020578
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The generic ingredient in ZOLADEX is goserelin acetate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the goserelin acetate profile page.
Summary for 020578
Tradename: | ZOLADEX |
Applicant: | Tersera |
Ingredient: | goserelin acetate |
Patents: | 0 |
Pharmacology for NDA: 020578
Mechanism of Action | Gonadotropin Releasing Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 020578
Suppliers and Packaging for NDA: 020578
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ZOLADEX | goserelin acetate | IMPLANT;IMPLANTATION | 020578 | NDA | TerSera Therapeutics LLC | 70720-951 | 70720-951-30 | 1 POUCH in 1 CARTON (70720-951-30) / 1 SYRINGE in 1 POUCH / 1 IMPLANT in 1 SYRINGE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | IMPLANT;IMPLANTATION | Strength | EQ 10.8MG BASE | ||||
Approval Date: | Jan 11, 1996 | TE: | RLD: | Yes |
Expired US Patents for NDA 020578
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Tersera | ZOLADEX | goserelin acetate | IMPLANT;IMPLANTATION | 020578-001 | Jan 11, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Tersera | ZOLADEX | goserelin acetate | IMPLANT;IMPLANTATION | 020578-001 | Jan 11, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Tersera | ZOLADEX | goserelin acetate | IMPLANT;IMPLANTATION | 020578-001 | Jan 11, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Tersera | ZOLADEX | goserelin acetate | IMPLANT;IMPLANTATION | 020578-001 | Jan 11, 1996 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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