Details for New Drug Application (NDA): 080911
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NDA 080911 describes TESTOPEL, which is a drug marketed by Endo Operations and is included in one NDA. It is available from one supplier. Additional details are available on the TESTOPEL profile page.
The generic ingredient in TESTOPEL is testosterone. There are sixty-nine drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the testosterone profile page.
The generic ingredient in TESTOPEL is testosterone. There are sixty-nine drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the testosterone profile page.
Summary for 080911
| Tradename: | TESTOPEL |
| Applicant: | Endo Operations |
| Ingredient: | testosterone |
| Patents: | 0 |
Pharmacology for NDA: 080911
| Mechanism of Action | Androgen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 080911
Suppliers and Packaging for NDA: 080911
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TESTOPEL | testosterone | PELLET;IMPLANTATION | 080911 | ANDA | Endo USA, Inc. | 66887-004 | 66887-004-10 | 10 AMPULE in 1 BOX (66887-004-10) / 1 PELLET in 1 AMPULE (66887-004-01) |
| TESTOPEL | testosterone | PELLET;IMPLANTATION | 080911 | ANDA | Endo USA, Inc. | 66887-004 | 66887-004-20 | 100 AMPULE in 1 BOX (66887-004-20) / 1 PELLET in 1 AMPULE (66887-004-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | PELLET;IMPLANTATION | Strength | 75MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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