Generic Companies with Tentative Approvals for: fexofenadine hydrochloride; pseudoephedrine hydrochloride
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fexofenadine hydrochloride; pseudoephedrine 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 |
---|---|---|---|---|
Mylan | fexofenadine hydrochloride; pseudoephedrine hydrochloride | 076538 | 60/120MG | TABLET, EXTENDED RELEASE; ORAL |
Pld Acquisitions Llc | fexofenadine hydrochloride; pseudoephedrine hydrochloride | 077999 | 60MG; 120MG | TABLET, EXTENDED RELEASE; ORAL |
Barr | fexofenadine hydrochloride; pseudoephedrine hydrochloride | 076236 | 60MG;120MG | TABLET, EXTENDED RELEASE;ORAL |
Wockhardt | fexofenadine hydrochloride; pseudoephedrine hydrochloride | 079115 | 60MG; 120MG | TABLET, EXTENDED RELEASE; ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |