Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206497
Company: MYLAN TECH VIATRIS
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 |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/30/2024 | SUPPL-2 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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 |