Generic Companies with Tentative Approvals for: Barr
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Barr 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 |
---|---|---|---|---|
Barr Labs Inc | aripiprazole | 078612 | 20MG | TABLET, ORALLY DISINTEGRATING; ORAL |
Barr | modafinil | 076597 | 200MG | Tablet; Oral |
Barr Labs Inc | aripiprazole | 078612 | 30MG | TABLET; ORALLY DISINTEGRATING |
Barr | fexofenadine hydrochloride; pseudoephedrine hydrochloride | 076236 | 60MG;120MG | TABLET, EXTENDED RELEASE;ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |