Details for New Drug Application (NDA): 206497
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The generic ingredient in METHYLPHENIDATE is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
Summary for 206497
Tradename: | METHYLPHENIDATE |
Applicant: | Mylan Tech Viatris |
Ingredient: | methylphenidate |
Patents: | 0 |
Pharmacology for NDA: 206497
Physiological Effect | Central Nervous System Stimulation |
Medical Subject Heading (MeSH) Categories for 206497
Suppliers and Packaging for NDA: 206497
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METHYLPHENIDATE | methylphenidate | FILM, EXTENDED RELEASE;TRANSDERMAL | 206497 | ANDA | Mylan Pharmaceuticals Inc. | 0378-8260 | 0378-8260-93 | 30 POUCH in 1 CARTON (0378-8260-93) / 1 PATCH in 1 POUCH (0378-8260-16) / 9 h in 1 PATCH |
METHYLPHENIDATE | methylphenidate | FILM, EXTENDED RELEASE;TRANSDERMAL | 206497 | ANDA | Mylan Pharmaceuticals Inc. | 0378-8261 | 0378-8261-93 | 30 POUCH in 1 CARTON (0378-8261-93) / 1 PATCH in 1 POUCH (0378-8261-16) / 9 h in 1 PATCH |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 10MG/9HR (1.1MG/HR) | ||||
Approval Date: | Mar 14, 2022 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 15MG/9HR (1.6MG/HR) | ||||
Approval Date: | Mar 14, 2022 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 20MG/9HR (2.2MG/HR) | ||||
Approval Date: | Mar 14, 2022 | TE: | AB | RLD: | No |
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