APPLICATION
ANDA203614
TYPE
ANDA
ORIGINAL APPROVAL
2017-07-05
LATEST ACTION
2024-08-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
DEXMETHYLPHENIDATE HYDROCHLORIDEPrescription
DEXMETHYLPHENIDATE HYDROCHLORIDE 25MG · CAPSULE, EXTENDED RELEASE · ORAL
DEXMETHYLPHENIDATE HYDROCHLORIDEPrescription
DEXMETHYLPHENIDATE HYDROCHLORIDE 35MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2024-08-21Labeling · Supplement 6 · standardAP
2024-08-21Labeling · Supplement 12 · standardAP
2024-08-21Labeling · Supplement 7 · standardAP
2024-08-21Labeling · Supplement 3 · standardAP
2019-11-29Labeling · Supplement 2 · standardAP
2017-07-05UNKNOWN · OriginalAP
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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