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FDA ANDA · ANDA207884

METHYLPHENIDATE HYDROCHLORIDE

Sponsor: NOVEL LABS INC

APPLICATION
ANDA207884
TYPE
ANDA
ORIGINAL APPROVAL
2015-11-13
LATEST ACTION
2024-04-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

METHYLPHENIDATE HYDROCHLORIDEPrescription
METHYLPHENIDATE HYDROCHLORIDE 10MG · TABLET · ORAL
METHYLPHENIDATE HYDROCHLORIDEPrescription
METHYLPHENIDATE HYDROCHLORIDE 20MG · TABLET · ORAL
METHYLPHENIDATE HYDROCHLORIDEPrescription
METHYLPHENIDATE HYDROCHLORIDE 5MG · TABLET · ORAL

Approval history

2024-04-01Labeling · Supplement 5 · standardAP
2023-06-23Labeling · Supplement 4 · standardAP
2023-06-23Labeling · Supplement 3 · standardAP
2015-11-13UNKNOWN · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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