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Last Updated: September 25, 2020

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Details for New Drug Application (NDA): 211796

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NDA 211796 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, Novel Labs Inc, Novelgenix Theraps, Quagen, Tris Pharma Inc, Ascent Pharms Inc, Rising, Able, Actavis Labs Fl, Alvogen Pine Brook, Amneal Pharms, Andor Pharms, Ani Pharms Inc, Cnty Line Pharms, Dr Reddys, Heritage Pharma, Lannett Co Inc, Mylan, Osmotica, Par Pharm, Watson Labs, Abhai Inc, Aurolife Pharma Llc, Bionpharma Inc, Cediprof Inc, Mountain, Oxford Pharms, Prinston Inc, and Sun Pharm Inds Inc, and is included in sixty-one NDAs. It is available from thirty-six 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-five suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
Summary for 211796
Tradename:METHYLPHENIDATE HYDROCHLORIDE
Applicant:Granules Pharms
Ingredient:methylphenidate hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 211796
Suppliers and Packaging for NDA: 211796
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 211796 ANDA Granules Pharmaceuticals Inc. 70010-012 70010-012-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-012-01)
METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 211796 ANDA Granules Pharmaceuticals Inc. 70010-013 70010-013-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-013-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MG
Approval Date:May 23, 2019TE:AB1RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength20MG
Approval Date:May 23, 2019TE:AB1RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength30MG
Approval Date:May 23, 2019TE:AB1RLD:No

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