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FDA ANDA · ANDA210279
DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE
dexmethylphenidate hydrochloride
Sponsor: ADARE PHARMS INC
APPLICATION
ANDA210279
TYPE
ANDA
ORIGINAL APPROVAL
2018-10-09
LATEST ACTION
2019-11-29
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
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
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
Approval history
2019-11-29Labeling · Supplement 2 · standardAP
2018-10-09UNKNOWN · Original · standardAP
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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