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Abbreviated New Drug Application (ANDA): 206497
Company: MYLAN TECH VIATRIS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHYLPHENIDATE METHYLPHENIDATE 10MG/9HR (1.1MG/HR) FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB No No
METHYLPHENIDATE METHYLPHENIDATE 15MG/9HR (1.6MG/HR) FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB No No
METHYLPHENIDATE METHYLPHENIDATE 20MG/9HR (2.2MG/HR) FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB No No
METHYLPHENIDATE METHYLPHENIDATE 30MG/9HR (3.3MG/HR) FILM, EXTENDED RELEASE;TRANSDERMAL 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
03/14/2022 ORIG-1 Approval STANDARD Letter (PDF)
Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/206497Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/206497Orig1s000.pdf

METHYLPHENIDATE

FILM, EXTENDED RELEASE;TRANSDERMAL; 10MG/9HR (1.1MG/HR)
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DAYTRANA METHYLPHENIDATE 10MG/9HR (1.1MG/HR) FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 021514 NOVEN PHARMS INC
METHYLPHENIDATE METHYLPHENIDATE 10MG/9HR (1.1MG/HR) FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 206497 MYLAN TECH VIATRIS

FILM, EXTENDED RELEASE;TRANSDERMAL; 15MG/9HR (1.6MG/HR)
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DAYTRANA METHYLPHENIDATE 15MG/9HR (1.6MG/HR) FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 021514 NOVEN PHARMS INC
METHYLPHENIDATE METHYLPHENIDATE 15MG/9HR (1.6MG/HR) FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 206497 MYLAN TECH VIATRIS

FILM, EXTENDED RELEASE;TRANSDERMAL; 20MG/9HR (2.2MG/HR)
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DAYTRANA METHYLPHENIDATE 20MG/9HR (2.2MG/HR) FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 021514 NOVEN PHARMS INC
METHYLPHENIDATE METHYLPHENIDATE 20MG/9HR (2.2MG/HR) FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 206497 MYLAN TECH VIATRIS

FILM, EXTENDED RELEASE;TRANSDERMAL; 30MG/9HR (3.3MG/HR)
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DAYTRANA METHYLPHENIDATE 30MG/9HR (3.3MG/HR) FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 021514 NOVEN PHARMS INC
METHYLPHENIDATE METHYLPHENIDATE 30MG/9HR (3.3MG/HR) FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 206497 MYLAN TECH VIATRIS
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