Generic Companies with Tentative Approvals for: buprenorphine hydrochloride; naloxone hydrochloride
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buprenorphine hydrochloride; naloxone hydrochloride 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 Ut Inc | buprenorphine hydrochloride; naloxone hydrochloride | 204383 | EQ 8MG BASE;EQ 2MG BASE | FILM;BUCCAL, SUBLINGUAL |
Sun Pharm Industries | buprenorphine hydrochloride; naloxone hydrochloride | 214737 | EQ 1.4MG BASE;EQ 0.36MG BASE | TABLET;SUBLINGUAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |