Details for New Drug Application (NDA): 206497
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NDA 206497 describes METHYLPHENIDATE, which is a drug marketed by Mylan Tech Viatris, Actavis Elizabeth, Barr Labs Inc, Dr Reddys Labs Sa, Granules, Impax Labs Inc, Specgx Llc, Teva Pharms, Actavis Labs Fl Inc, Abhai Llc, Alkem Labs Ltd, Anda Repository, Ascent Pharms Inc, Breckenridge, Chartwell Molecular, Novel Labs Inc, Quagen, Tris Pharma Inc, Wes Pharma Inc, Nostrum Labs Inc, Rising, Able, Actavis Labs Fl, Alvogen, Amneal Pharms, Andor Pharms, Ani Pharms, Aurolife Pharma Llc, Dr Reddys, Heritage Pharma, Lannett Co Inc, Osmotica Pharm Us, Rhodes Pharms, Strides Pharma, Sun Pharm Inds Inc, Watson Labs, Abhai Inc, Accord Hlthcare, Bionpharma, Cediprof Inc, Mountain, Oxford Pharms, and Prinston Inc, and is included in seventy-one NDAs. It is available from one supplier. Additional details are available on the METHYLPHENIDATE profile page.
The generic ingredient in METHYLPHENIDATE is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
The generic ingredient in METHYLPHENIDATE is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Forty-seven 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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