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 | cinacalcet hydrochloride | 090476 | 30MG | TABLET; ORAL |
| Barr Labs Inc | aripiprazole | 078612 | 20MG | TABLET, ORALLY DISINTEGRATING; ORAL |
| Barr Labs Inc | aripiprazole | 078613 | 30MG | TABLET; ORAL |
| Barr | topiramate | 076315 | 25MG | TABLET;ORAL |
| Barr | fexofenadine hydrochloride; pseudoephedrine hydrochloride | 076236 | 60MG;120MG | TABLET, EXTENDED RELEASE;ORAL |
| Barr Labs Inc | aripiprazole | 078613 | 15MG | TABLET; ORAL |
| Barr | cinacalcet hydrochloride | 090476 | 90MG | TABLET; ORAL |
| >Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |
