Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206049
Company: ACTAVIS LABS FL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG/ML FOR SUSPENSION, EXTENDED RELEASE;ORAL Prescription AB 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
05/17/2018 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206049Orig1s000ltr.pdf

METHYLPHENIDATE HYDROCHLORIDE

FOR SUSPENSION, EXTENDED RELEASE;ORAL; 5MG/ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG/ML FOR SUSPENSION, EXTENDED RELEASE;ORAL Prescription No AB 206049 ACTAVIS LABS FL INC
QUILLIVANT XR METHYLPHENIDATE HYDROCHLORIDE 5MG/ML FOR SUSPENSION, EXTENDED RELEASE;ORAL Prescription Yes AB 202100 NEXTWAVE

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