Details for New Drug Application (NDA): 206368
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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 206368
Tradename: | TESTOSTERONE CYPIONATE |
Applicant: | Wilshire Pharms Inc |
Ingredient: | testosterone cypionate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 206368
Mechanism of Action | Androgen Receptor Agonists |
Suppliers and Packaging for NDA: 206368
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TESTOSTERONE CYPIONATE | testosterone cypionate | INJECTABLE;INJECTION | 206368 | ANDA | Wilshire Pharmaceuticals | 52536-625 | 52536-625-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (52536-625-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
TESTOSTERONE CYPIONATE | testosterone cypionate | INJECTABLE;INJECTION | 206368 | ANDA | Wilshire Pharmaceuticals | 52536-625 | 52536-625-10 | 1 VIAL, MULTI-DOSE in 1 CARTON (52536-625-10) / 10 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 200MG/ML | ||||
Approval Date: | Apr 24, 2019 | TE: | AO | RLD: | No |
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