Test - Generic Drug Details
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Generic filers with tentative approvals for TEST
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Start Trial | ⤷ Start Trial | 30MG/1.5ML ACTUATION | SOLUTION, METERED;TRANSDERMAL |
| ⤷ Start Trial | ⤷ Start Trial | 750MG/3ML (250MG/ML) | INJECTABLE;INTRAMUSCULAR |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
US Patents and Regulatory Information for test
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbvie | ANDRODERM | testosterone | FILM, EXTENDED RELEASE;TRANSDERMAL | 020489-002 | May 2, 1997 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Antares Pharma Inc | XYOSTED (AUTOINJECTOR) | testosterone enanthate | SOLUTION;SUBCUTANEOUS | 209863-003 | Sep 28, 2018 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Perrigo Israel | TESTOSTERONE | testosterone | GEL, METERED;TRANSDERMAL | 203098-001 | Jan 31, 2013 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Bel Mar | TESTOSTERONE PROPIONATE | testosterone propionate | INJECTABLE;INJECTION | 080743-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Hikma | TESTOSTERONE CYPIONATE | testosterone cypionate | INJECTABLE;INJECTION | 090387-002 | Jul 15, 2010 | AO | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
