Generic Companies with Tentative Approvals for: Actavis Labs
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Actavis Labs Generic Filers with Tentative Approvals
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
| Applicant | Generic Name | NDA | Strength | Dosage Form |
|---|---|---|---|---|
| Actavis Labs Fl Inc | acetaminophen; oxycodone hydrochloride | 207113 | 325MG; 7.5MG | TABLET, EXTENDED RELEASE;ORAL |
| Actavis Labs Fl Inc | oxcarbazepine | 205444 | 600MG | TABLET, EXTENDED RELEASE;ORAL |
| Actavis Labs | treprostinil | 208906 | 0.125MG | TABLET, EXTENDED RELEASE;ORAL |
| Actavis Labs | ingenol mebutate | 209086 | 0.05% | GEL; TOPICAL |
| Actavis Labs Ut Inc | buprenorphine hydrochloride; naloxone hydrochloride | 204383 | EQ 8MG BASE;EQ 2MG BASE | FILM;BUCCAL, SUBLINGUAL |
| Actavis Labs Fl Inc | oxcarbazepine | 205444 | 150MG | TABLET, EXTENDED RELEASE;ORAL |
| >Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |
