Generic Companies with Tentative Approvals for: Astrazeneca Ab
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Astrazeneca Ab 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 |
---|---|---|---|---|
Astrazeneca Ab | dapagliflozin; metformin hydrochloride | 205649 | 2.5MG;1GM | TABLET, EXTENDED RELEASE;ORAL |
Astrazeneca Ab | dapagliflozin; metformin hydrochloride | 205649 | 5MG;1GM | TABLET, EXTENDED RELEASE;ORAL |
Astrazeneca Ab | dapagliflozin; metformin hydrochloride | 205649 | 10MG;500MG | TABLET, EXTENDED RELEASE;ORAL |
Astrazeneca Ab | dapagliflozin; metformin hydrochloride | 205649 | 5MG;500MG | TABLET, EXTENDED RELEASE;ORAL |
Astrazeneca Ab | dapagliflozin; metformin hydrochloride | 205649 | 10MG;1GM | TABLET, EXTENDED RELEASE;ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |