Details for New Drug Application (NDA): 212984
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NDA 212984 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 Intl, Dr Reddys, Watson Labs, Apotex, Cipla, Am Regent, Caplin One Labs, Eugia Pharma, Hikma, Hikma Farmaceutica, Padagis Us, Rising, Sun Pharm Inds Ltd, Watson Pharms Inc, Wilshire Pharms Inc, Nexus, Bel Mar, Elkins Sinn, and Lilly, and is included in fifty-nine NDAs. It is available from twelve suppliers. Additional details are available on the TESTOSTERONE profile page.
The generic ingredient in TESTOSTERONE is testosterone propionate. There are six 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 six drug master file entries for this compound. Additional details are available on the testosterone propionate profile page.
Summary for 212984
| Tradename: | TESTOSTERONE |
| Applicant: | Encube |
| Ingredient: | testosterone |
| Patents: | 0 |
Pharmacology for NDA: 212984
| Mechanism of Action | Androgen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 212984
Suppliers and Packaging for NDA: 212984
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TESTOSTERONE | testosterone | GEL, METERED;TRANSDERMAL | 212984 | ANDA | Encube Ethicals, Inc. | 21922-019 | 21922-019-02 | 30 PACKET in 1 CARTON (21922-019-02) / 5 g in 1 PACKET |
| TESTOSTERONE | testosterone | GEL, METERED;TRANSDERMAL | 212984 | ANDA | Encube Ethicals, Inc. | 21922-019 | 21922-019-47 | 2 CONTAINER in 1 CARTON (21922-019-47) / 75 g in 1 CONTAINER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TRANSDERMAL | Strength | 50MG/5GM PACKET | ||||
| Approval Date: | Nov 9, 2021 | TE: | AB1 | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL, METERED;TRANSDERMAL | Strength | 12.5MG/1.25GM ACTUATION | ||||
| Approval Date: | Feb 9, 2024 | TE: | AB1 | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TRANSDERMAL | Strength | 25MG/2.5GM PACKET | ||||
| Approval Date: | Jul 11, 2024 | TE: | AB1 | RLD: | No | ||||
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