← FDA DRUG APPROVALS

FDA ANDA · ANDA202842

DEXMETHYLPHENIDATE HYDROCHLORIDE

Sponsor: PH HEALTH

APPLICATION
ANDA202842
TYPE
ANDA
ORIGINAL APPROVAL
2016-11-30
LATEST ACTION
2021-11-01
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

2021-11-01Labeling · Supplement 8 · standardAP
2019-11-29Labeling · Supplement 4 · standardAP
2019-11-29Labeling · Supplement 1 · standardAP
2016-11-30UNKNOWN · Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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