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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208861
Company: ACTAVIS ELIZABETH

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB3 No No
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 15MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB3 No No
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB3 No No
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 30MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB3 No No
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 40MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB3 No No
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 50MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB3 No No
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB3 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
12/13/2018 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208861Orig1s000TAltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/12/2023 SUPPL-7 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
07/12/2023 SUPPL-1 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

METHYLPHENIDATE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL; 10MG
TE Code = AB3

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
APTENSIO XR METHYLPHENIDATE HYDROCHLORIDE 10MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB3 205831 RHODES PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 208861 ACTAVIS ELIZABETH

CAPSULE, EXTENDED RELEASE;ORAL; 15MG
TE Code = AB3

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
APTENSIO XR METHYLPHENIDATE HYDROCHLORIDE 15MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB3 205831 RHODES PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 15MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 208861 ACTAVIS ELIZABETH

CAPSULE, EXTENDED RELEASE;ORAL; 20MG
TE Code = AB3

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
APTENSIO XR METHYLPHENIDATE HYDROCHLORIDE 20MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB3 205831 RHODES PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 208861 ACTAVIS ELIZABETH

CAPSULE, EXTENDED RELEASE;ORAL; 30MG
TE Code = AB3

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
APTENSIO XR METHYLPHENIDATE HYDROCHLORIDE 30MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB3 205831 RHODES PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 30MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 208861 ACTAVIS ELIZABETH

CAPSULE, EXTENDED RELEASE;ORAL; 40MG
TE Code = AB3

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
APTENSIO XR METHYLPHENIDATE HYDROCHLORIDE 40MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB3 205831 RHODES PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 40MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 208861 ACTAVIS ELIZABETH

CAPSULE, EXTENDED RELEASE;ORAL; 50MG
TE Code = AB3

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
APTENSIO XR METHYLPHENIDATE HYDROCHLORIDE 50MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB3 205831 RHODES PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 50MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 208861 ACTAVIS ELIZABETH

CAPSULE, EXTENDED RELEASE;ORAL; 60MG
TE Code = AB3

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
APTENSIO XR METHYLPHENIDATE HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB3 205831 RHODES PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 208861 ACTAVIS ELIZABETH
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