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FDA ANDA · ANDA208756

DEXMETHYLPHENIDATE HYDROCHLORIDE

Sponsor: RHODES PHARMS

APPLICATION
ANDA208756
TYPE
ANDA
ORIGINAL APPROVAL
2017-11-20
LATEST ACTION
2017-11-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

DEXMETHYLPHENIDATE HYDROCHLORIDEDiscontinued
DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG · TABLET · ORAL
DEXMETHYLPHENIDATE HYDROCHLORIDEDiscontinued
DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG · TABLET · ORAL
DEXMETHYLPHENIDATE HYDROCHLORIDEDiscontinued
DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG · TABLET · ORAL

Approval history

2017-11-20UNKNOWN · Original · standardAP
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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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