Details for New Drug Application (NDA): 091244
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NDA 091244 describes TESTOSTERONE CYPIONATE, which is a drug marketed by Am Regent, Cipla, Eugia Pharma, Hikma, Hikma Farmaceutica, Padagis Us, Rising, Sandoz, Sun Pharm Inds Ltd, Watson Labs, Watson Pharms Inc, Wilshire Pharms Inc, Xiromed, and Slayback Pharma Llc, and is included in sixteen NDAs. It is available from fifteen suppliers. There are two patents protecting this drug. Additional details are available on the TESTOSTERONE CYPIONATE profile page.
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.
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 091244
| Tradename: | TESTOSTERONE CYPIONATE |
| Applicant: | Hikma Farmaceutica |
| Ingredient: | testosterone cypionate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 091244
| Mechanism of Action | Androgen Receptor Agonists |
Suppliers and Packaging for NDA: 091244
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TESTOSTERONE CYPIONATE | testosterone cypionate | INJECTABLE;INJECTION | 091244 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9005 | 0143-9005-01 | 1 VIAL in 1 CARTON (0143-9005-01) / 10 mL in 1 VIAL |
| TESTOSTERONE CYPIONATE | testosterone cypionate | INJECTABLE;INJECTION | 091244 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9659 | 0143-9659-01 | 1 mL in 1 VIAL (0143-9659-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 200MG/ML | ||||
| Approval Date: | May 1, 2012 | TE: | AO | RLD: | No | ||||
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