Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200886
Company: MAYNE PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB1 No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/26/2018 ORIG-1 Approval Not Applicable

Label is not available on this site.

METHYLPHENIDATE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL; 10MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB1 211796 GRANULES PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB1 200886 MAYNE PHARMA
RITALIN LA METHYLPHENIDATE HYDROCHLORIDE 10MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB1 021284 NOVARTIS

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