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Details for New Drug Application (NDA): 210818
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NDA 210818 describes METHYLPHENIDATE HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Barr Labs Inc, Granules Pharms, Impax Labs Inc, Mayne Pharma, Specgx Llc, Teva Pharms, Actavis Labs Fl Inc, Abhai Llc, Alkem Labs Ltd, Anda Repository, Breckenridge, Eywa, Lannett Co Inc, Novel Labs Inc, Quagen, Tris Pharma Inc, Ascent Pharms Inc, Nostrum Labs Inc, Rising, Able, Actavis Labs Fl, Alvogen Pine Brook, Amneal Pharms, Andor Pharms, Ani Pharms Inc, Cnty Line Pharms, Dr Reddys, Heritage Pharma, Mylan, Osmotica, Par Pharm, Sun Pharm Inds Inc, Watson Labs, Abhai Inc, Accord Hlthcare, Aurolife Pharma Llc, Cediprof Inc, Mountain, Oxford Pharms, Prinston Inc, and Uspharma, and is included in sixty-five NDAs. It is available from thirty-five suppliers. Additional details are available on the METHYLPHENIDATE HYDROCHLORIDE profile page.
The generic ingredient in METHYLPHENIDATE HYDROCHLORIDE is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
The generic ingredient in METHYLPHENIDATE HYDROCHLORIDE is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
Summary for 210818
| Tradename: | METHYLPHENIDATE HYDROCHLORIDE |
| Applicant: | Alvogen Pine Brook |
| Ingredient: | methylphenidate hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 210818
| Physiological Effect | Central Nervous System Stimulation |
Suppliers and Packaging for NDA: 210818
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METHYLPHENIDATE HYDROCHLORIDE | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 210818 | ANDA | Alvogen Inc. | 47781-415 | 47781-415-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (47781-415-01) |
| METHYLPHENIDATE HYDROCHLORIDE | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 210818 | ANDA | Alvogen Inc. | 47781-416 | 47781-416-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (47781-416-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 18MG | ||||
| Approval Date: | Nov 30, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 27MG | ||||
| Approval Date: | Nov 30, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 36MG | ||||
| Approval Date: | Nov 30, 2018 | TE: | AB | RLD: | No | ||||
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