APPLICATION
ANDA214202
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE, CHEWABLE
MARKETING STATUS
None (Tentative Approval)
Products
METHYLPHENIDATE HYDROCHLORIDENone (Tentative Approval)
METHYLPHENIDATE HYDROCHLORIDE 40MG · TABLET, EXTENDED RELEASE, CHEWABLE · ORAL
METHYLPHENIDATE HYDROCHLORIDENone (Tentative Approval)
METHYLPHENIDATE HYDROCHLORIDE 20MG · TABLET, EXTENDED RELEASE, CHEWABLE · ORAL
METHYLPHENIDATE HYDROCHLORIDENone (Tentative Approval)
METHYLPHENIDATE HYDROCHLORIDE 30MG · TABLET, EXTENDED RELEASE, CHEWABLE · ORAL
Approval history
2023-02-07UNKNOWN · Original · standardTA
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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