Details for New Drug Application (NDA): 080911
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The generic ingredient in TESTOPEL is testosterone. There are sixty-nine drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the testosterone profile page.
Summary for 080911
Tradename: | TESTOPEL |
Applicant: | Auxilium Pharms Inc |
Ingredient: | testosterone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
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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