News about "ADZENYS XR-ODT"

Granules Pharmaceuticals Secures US FDA Tentative Approval for gDYANAVEL XR

Granules Pharmaceuticals Secures US FDA Tentative Approval for gDYANAVEL XR

The tentative approval clears a key regulatory milestone for Granules Pharmaceuticals’ Abbreviated New Drug Application (ANDA), which the US FDA has determined to be eligible for 180-day market exclusivity.

ADZENYS XR-ODT | 09/01/2026 | By News Bureau

Granules Pharma Gets US FDA Tentative Approval for Generic ADZENYS XR-ODT

Granules Pharma Gets US FDA Tentative Approval for Generic ADZENYS XR-ODT

Granules Pharmaceuticals Inc has received tentative approval from the US FDA for its generic version of Amphetamine Extended-Release Orally Disintegrating Tablets (ADZENYS XR-ODT), which will be manufactured at the company’s US-based facility in Chantilly, Virginia.

ADZENYS XR-ODT | 22/12/2025 | By News Bureau 102


 

 

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