Details for New Drug Application (NDA): 216318
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The generic ingredient in TESTOSTERONE CYPIONATE is estradiol cypionate; testosterone cypionate. There are seventy-five drug master file entries for this compound. Additional details are available on the estradiol cypionate; testosterone cypionate profile page.
Summary for 216318
Tradename: | TESTOSTERONE CYPIONATE |
Applicant: | Slayback Pharma Llc |
Ingredient: | testosterone cypionate |
Patents: | 2 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 216318
Mechanism of Action | Androgen Receptor Agonists |
Suppliers and Packaging for NDA: 216318
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TESTOSTERONE CYPIONATE | testosterone cypionate | SOLUTION;INTRAMUSCULAR | 216318 | NDA | Slayback Pharma LLC | 71225-127 | 71225-127-01 | 1 VIAL in 1 CARTON (71225-127-01) / 1 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAMUSCULAR | Strength | 200MG/ML (200MG/ML) | ||||
Approval Date: | Jun 2, 2022 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 25, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 25, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? |
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