Details for New Drug Application (NDA): 205781
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NDA 205781 describes TESTOSTERONE, which is a drug marketed by Actavis Labs Ut Inc, Alembic, Amneal, Encube, Lupin, Padagis Israel, Perrigo Israel, Twi Pharms, Xiromed, Ani Pharms, Strides Pharma, Dr Reddys, Watson Labs, Apotex, Cipla, Lupin Ltd, Am Regent, Eugia Pharma, Hikma, Hikma Farmaceutica, Padagis Us, Rising, Sandoz, Sun Pharm Inds Ltd, Watson Pharms Inc, Wilshire Pharms Inc, Azurity, Nexus, Bel Mar, Elkins Sinn, and Lilly, and is included in sixty NDAs. It is available from fourteen suppliers. There are two patents protecting this drug. Additional details are available on the TESTOSTERONE profile page.
The generic ingredient in TESTOSTERONE is testosterone propionate. There are sixty-nine drug master file entries for this compound. Additional details are available on the testosterone propionate profile page.
The generic ingredient in TESTOSTERONE is testosterone propionate. There are sixty-nine drug master file entries for this compound. Additional details are available on the testosterone propionate profile page.
Summary for 205781
| Tradename: | TESTOSTERONE |
| Applicant: | Padagis Israel |
| Ingredient: | testosterone |
| Patents: | 0 |
Pharmacology for NDA: 205781
| Mechanism of Action | Androgen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 205781
Suppliers and Packaging for NDA: 205781
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TESTOSTERONE | testosterone | GEL;TRANSDERMAL | 205781 | ANDA | Northstar Rx LLC | 16714-968 | 16714-968-02 | 30 PACKET in 1 CARTON (16714-968-02) / 1.25 g in 1 PACKET (16714-968-01) |
| TESTOSTERONE | testosterone | GEL;TRANSDERMAL | 205781 | ANDA | Northstar Rx LLC | 16714-969 | 16714-969-02 | 30 PACKET in 1 CARTON (16714-969-02) / 2.5 g in 1 PACKET (16714-969-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TRANSDERMAL | Strength | 1.62% (20.25MG/1.25GM PACKET) | ||||
| Approval Date: | Jul 12, 2017 | TE: | AB2 | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TRANSDERMAL | Strength | 1.62% (40.5MG/2.5GM PACKET) | ||||
| Approval Date: | Jul 12, 2017 | TE: | AB2 | RLD: | No | ||||
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