Details for New Drug Application (NDA): 210362
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NDA 210362 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 Azurity, and is included in sixteen NDAs. It is available from seventeen 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 210362
| Tradename: | TESTOSTERONE CYPIONATE |
| Applicant: | Cipla |
| Ingredient: | testosterone cypionate |
| Patents: | 0 |
Pharmacology for NDA: 210362
| Mechanism of Action | Androgen Receptor Agonists |
Suppliers and Packaging for NDA: 210362
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TESTOSTERONE CYPIONATE | testosterone cypionate | INJECTABLE;INJECTION | 210362 | ANDA | Cipla USA Inc. | 69097-536 | 69097-536-37 | 10 mL in 1 VIAL, GLASS (69097-536-37) |
| TESTOSTERONE CYPIONATE | testosterone cypionate | INJECTABLE;INJECTION | 210362 | ANDA | Cipla USA Inc. | 69097-537 | 69097-537-31 | 1 mL in 1 VIAL, GLASS (69097-537-31) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 100MG/ML | ||||
| Approval Date: | Jun 19, 2018 | TE: | AO | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 200MG/ML | ||||
| Approval Date: | Jun 19, 2018 | TE: | AO | RLD: | No | ||||
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