Details for New Drug Application (NDA): 204399
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NDA 204399 describes VOGELXO, which is a drug marketed by Upsher Smith Labs and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the VOGELXO profile page.
The generic ingredient in VOGELXO 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 VOGELXO 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 204399
| Tradename: | VOGELXO |
| Applicant: | Upsher Smith Labs |
| Ingredient: | testosterone |
| Patents: | 3 |
Pharmacology for NDA: 204399
| Mechanism of Action | Androgen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 204399
Suppliers and Packaging for NDA: 204399
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VOGELXO | testosterone | GEL, METERED;TRANSDERMAL | 204399 | NDA | Upsher-Smith Laboratories, LLC | 0245-0871 | 0245-0871-05 | 30 TUBE in 1 CARTON (0245-0871-05) / 5 g in 1 TUBE (0245-0871-65) |
| VOGELXO | testosterone | GEL, METERED;TRANSDERMAL | 204399 | NDA | Upsher-Smith Laboratories, LLC | 0245-0871 | 0245-0871-35 | 30 PACKET in 1 CARTON (0245-0871-35) / 5 g in 1 PACKET (0245-0871-89) |
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TRANSDERMAL | Strength | 50MG/5GM PACKET | ||||
| Approval Date: | Jun 4, 2014 | TE: | AB2 | RLD: | No | ||||
| Patent: | 8,785,426 | Patent Expiration: | Feb 11, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD FOR TRANSDERMAL DELIVERY OF TESTOSTERONE | ||||||||
| Patent: | 9,295,675 | Patent Expiration: | Feb 11, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD FOR TRANSDERMAL DELIVERY OF TESTOSTERONE | ||||||||
| Patent: | 9,662,340 | Patent Expiration: | Feb 11, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD FOR TRANSDERMAL DELIVERY OF TESTOSTERONE | ||||||||
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