Generic Companies with Tentative Approvals for: duloxetine hydrochloride
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duloxetine 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 |
---|---|---|---|---|
Sandoz | duloxetine hydrochloride | 090775 | 30MG | CAPSULE, DELAYED RELEASE; ORAL |
Sandoz | duloxetine hydrochloride | 090775 | 60MG | CAPSULE, DELAYED RELEASE; ORAL |
Sandoz | duloxetine hydrochloride | 090775 | 20MG | CAPSULE, DELAYED RELEASE; ORAL |
Wockhardt | duloxetine hydrochloride | 090773 | 60MG | CAPSULE, DELAYED RELEASE; ORAL |
Wockhardt | duloxetine hydrochloride | 090773 | 30MG | CAPSULE, DELAYED RELEASE; ORAL |
Impax Labs Inc | duloxetine hydrochloride | 090669 | EQ 30MG BASE | CAPSULE, DELAYED RELEASE; ORAL |
Impax Labs Inc | duloxetine hydrochloride | 090669 | EQ 60MG BASE | CAPSULE, DELAYED RELEASE; ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |