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FDA ANDA · ANDA078458

METHYLPHENIDATE HYDROCHLORIDE (LA)

methylphenidate hydrochloride

Sponsor: DR REDDYS LABS SA

APPLICATION
ANDA078458
TYPE
ANDA
ORIGINAL APPROVAL
2011-12-01
LATEST ACTION
2024-04-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

METHYLPHENIDATE HYDROCHLORIDEPrescription
METHYLPHENIDATE HYDROCHLORIDE 40MG · CAPSULE, EXTENDED RELEASE · ORAL
METHYLPHENIDATE HYDROCHLORIDEPrescription
METHYLPHENIDATE HYDROCHLORIDE 20MG · CAPSULE, EXTENDED RELEASE · ORAL
METHYLPHENIDATE HYDROCHLORIDEPrescription
METHYLPHENIDATE HYDROCHLORIDE 60MG · CAPSULE, EXTENDED RELEASE · ORAL
METHYLPHENIDATE HYDROCHLORIDEPrescription
METHYLPHENIDATE HYDROCHLORIDE 30MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2024-04-01Labeling · Supplement 20 · standardAP
2022-09-14Labeling · Supplement 15 · standardAP
2022-09-14Labeling · Supplement 16 · standardAP
2022-09-14Labeling · Supplement 14 · standardAP
2018-03-23Labeling · Supplement 11 · standardAP
2018-03-23Manufacturing (CMC) · Supplement 12AP
2016-06-23Manufacturing (CMC) · Supplement 10 — Letter ↗AP
2016-03-05Labeling · Supplement 9 · standardAP
2014-03-17Labeling · Supplement 8 · standardAP
2014-01-22Labeling · Supplement 5 · standardAP
2011-12-01Original — Review ↗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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