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ANDA approval
Tag: ANDA approval
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Granules Pharmaceuticals, Inc. Receives FDA Tentative Approval with 180-Day Exclusivity for Generic Amphetamine Extended-Release Tablets (gDYANAVEL XR)
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January 9, 2026
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Granules Pharmaceuticals Inc. Receives FDA Tentative Approval for Generic Amphetamine Extended-Release Orally Disintegrating Tablets (ADZENYS XR-ODT®)
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December 22, 2025
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Alembic Pharmaceuticals Limited receives USFDA Final Approval for Macitentan Tablets
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August 19, 2025
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Zydus Receives Final Approval From USFDA For Glatiramer Acetate Injection, The Generic Version Of Copaxone® 20 Mg/Ml, 40 Mg/Ml, Single-Dose Prefilled Syringes
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May 9, 2025
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Glenmark Pharmaceuticals receives ANDA approval for Saxagliptin Tablets, 2.5 mg and 5 mg
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August 1, 2023
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Glenmark receives ANDA approval for Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg
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March 20, 2023
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