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FDA ANDA · ANDA206734

DEXMETHYLPHENIDATE HYDROCHLORIDE

Sponsor: SUN PHARM INDS INC

APPLICATION

ANDA206734

TYPE

ANDA

ORIGINAL APPROVAL

2021-11-05

LATEST ACTION

2024-04-01

ROUTE

ORAL

DOSAGE FORM

CAPSULE, EXTENDED RELEASE

MARKETING STATUS

Discontinued

Products

DEXMETHYLPHENIDATE HYDROCHLORIDEDiscontinued

DEXMETHYLPHENIDATE HYDROCHLORIDE 40MG · CAPSULE, EXTENDED RELEASE · ORAL

DEXMETHYLPHENIDATE HYDROCHLORIDEDiscontinued

DEXMETHYLPHENIDATE HYDROCHLORIDE 30MG · CAPSULE, EXTENDED RELEASE · ORAL

DEXMETHYLPHENIDATE HYDROCHLORIDEDiscontinued

DEXMETHYLPHENIDATE HYDROCHLORIDE 20MG · CAPSULE, EXTENDED RELEASE · ORAL

DEXMETHYLPHENIDATE HYDROCHLORIDEDiscontinued

DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG · CAPSULE, EXTENDED RELEASE · ORAL

DEXMETHYLPHENIDATE HYDROCHLORIDEDiscontinued

DEXMETHYLPHENIDATE HYDROCHLORIDE 35MG · CAPSULE, EXTENDED RELEASE · ORAL

DEXMETHYLPHENIDATE HYDROCHLORIDEDiscontinued

DEXMETHYLPHENIDATE HYDROCHLORIDE 25MG · CAPSULE, EXTENDED RELEASE · ORAL

DEXMETHYLPHENIDATE HYDROCHLORIDEDiscontinued

DEXMETHYLPHENIDATE HYDROCHLORIDE 15MG · CAPSULE, EXTENDED RELEASE · ORAL

DEXMETHYLPHENIDATE HYDROCHLORIDEDiscontinued

DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2024-04-01Labeling · Supplement 5 · standardAP

2021-11-05UNKNOWN · Original · standardAP

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Related on SPEQ

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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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