← FDA DRUG APPROVALS

FDA ANDA · ANDA215523

DEXMETHYLPHENIDATE HYDROCHLORIDE

Sponsor: ASCENT PHARMS INC

APPLICATION
ANDA215523
TYPE
ANDA
ORIGINAL APPROVAL
2021-12-08
LATEST ACTION
2025-01-15
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

DEXMETHYLPHENIDATE HYDROCHLORIDEPrescription
DEXMETHYLPHENIDATE HYDROCHLORIDE 40MG · CAPSULE, EXTENDED RELEASE · ORAL
DEXMETHYLPHENIDATE HYDROCHLORIDEPrescription
DEXMETHYLPHENIDATE HYDROCHLORIDE 30MG · CAPSULE, EXTENDED RELEASE · ORAL
DEXMETHYLPHENIDATE HYDROCHLORIDEPrescription
DEXMETHYLPHENIDATE HYDROCHLORIDE 20MG · CAPSULE, EXTENDED RELEASE · ORAL
DEXMETHYLPHENIDATE HYDROCHLORIDEPrescription
DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG · CAPSULE, EXTENDED RELEASE · ORAL
DEXMETHYLPHENIDATE HYDROCHLORIDEPrescription
DEXMETHYLPHENIDATE HYDROCHLORIDE 35MG · CAPSULE, EXTENDED RELEASE · ORAL
DEXMETHYLPHENIDATE HYDROCHLORIDEPrescription
DEXMETHYLPHENIDATE HYDROCHLORIDE 25MG · CAPSULE, EXTENDED RELEASE · ORAL
DEXMETHYLPHENIDATE HYDROCHLORIDEPrescription
DEXMETHYLPHENIDATE HYDROCHLORIDE 15MG · CAPSULE, EXTENDED RELEASE · ORAL
DEXMETHYLPHENIDATE HYDROCHLORIDEPrescription
DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2025-01-15Labeling · Supplement 3 · standardAP
2021-12-08UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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