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FDA ANDA · ANDA202731

DEXMETHYLPHENIDATE HYDROCHLORIDE

Sponsor: TEVA PHARMS USA

APPLICATION
ANDA202731
TYPE
ANDA
ORIGINAL APPROVAL
2013-11-19
LATEST ACTION
2024-08-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

DEXMETHYLPHENIDATE HYDROCHLORIDEPrescription
DEXMETHYLPHENIDATE HYDROCHLORIDE 35MG · CAPSULE, EXTENDED RELEASE · ORAL
DEXMETHYLPHENIDATE HYDROCHLORIDEPrescription
DEXMETHYLPHENIDATE HYDROCHLORIDE 40MG · CAPSULE, EXTENDED RELEASE · ORAL
DEXMETHYLPHENIDATE HYDROCHLORIDEPrescription
DEXMETHYLPHENIDATE HYDROCHLORIDE 30MG · CAPSULE, EXTENDED RELEASE · ORAL
DEXMETHYLPHENIDATE HYDROCHLORIDEPrescription
DEXMETHYLPHENIDATE HYDROCHLORIDE 30MG · CAPSULE, EXTENDED RELEASE · ORAL
DEXMETHYLPHENIDATE HYDROCHLORIDEPrescription
DEXMETHYLPHENIDATE HYDROCHLORIDE 25MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2024-08-21Labeling · Supplement 11 · standardAP
2024-08-21Labeling · Supplement 19 · standardAP
2024-08-21Labeling · Supplement 15 · standardAP
2019-11-29Labeling · Supplement 5 · standardAP
2019-11-29Labeling · Supplement 10 · standardAP
2017-07-05UNKNOWN · OriginalAP
2015-08-13Labeling · Supplement 4 · standardAP
2014-05-19UNKNOWN · OriginalAP
2014-01-28Labeling · Supplement 2 · standardAP
2013-11-19UNKNOWN · 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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