Details for New Drug Application (NDA): 091120
✉ Email this page to a colleague
NDA 091120 describes TESTOSTERONE ENANTHATE, which is a drug marketed by Eugia Pharma, Hikma Farmaceutica, Nexus, Rising, Watson Labs, and Watson Pharms Inc, and is included in nine NDAs. It is available from two suppliers. Additional details are available on the TESTOSTERONE ENANTHATE profile page.
The generic ingredient in TESTOSTERONE ENANTHATE is estradiol valerate; testosterone enanthate. There are seventy-five drug master file entries for this compound. Additional details are available on the estradiol valerate; testosterone enanthate profile page.
The generic ingredient in TESTOSTERONE ENANTHATE is estradiol valerate; testosterone enanthate. There are seventy-five drug master file entries for this compound. Additional details are available on the estradiol valerate; testosterone enanthate profile page.
Summary for 091120
| Tradename: | TESTOSTERONE ENANTHATE |
| Applicant: | Hikma Farmaceutica |
| Ingredient: | testosterone enanthate |
| Patents: | 0 |
Pharmacology for NDA: 091120
| Mechanism of Action | Androgen Receptor Agonists |
Suppliers and Packaging for NDA: 091120
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TESTOSTERONE ENANTHATE | testosterone enanthate | INJECTABLE;INJECTION | 091120 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9750 | 0143-9750-01 | 5 mL in 1 VIAL, MULTI-DOSE (0143-9750-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 200MG/ML | ||||
| Approval Date: | Sep 18, 2012 | TE: | AO | RLD: | No | ||||
Complete Access Available with Subscription
