Application 211796

Type: ANDA
Sponsor: GRANULES PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	10MG	No	No
002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	20MG	No	No
003	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	30MG	No	No
004	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	40MG	No	No
005	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	60MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70010-012	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Granules Pharmaceuticals Inc.	ANDA	Current
70010-012	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Granules Pharmaceuticals Inc.	ANDA	Current
70010-012	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Granules Pharmaceuticals Inc.	ANDA	Current
70010-012	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Granules Pharmaceuticals Inc.	ANDA	Current
70010-013	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Granules Pharmaceuticals Inc.	ANDA	Current
70010-013	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Granules Pharmaceuticals Inc.	ANDA	Current
70010-013	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Granules Pharmaceuticals Inc.	ANDA	Current
70010-013	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Granules Pharmaceuticals Inc.	ANDA	Current
70010-014	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Granules Pharmaceuticals Inc.	ANDA	Current
70010-014	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Granules Pharmaceuticals Inc.	ANDA	Current
70010-014	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Granules Pharmaceuticals Inc.	ANDA	Current
70010-014	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Granules Pharmaceuticals Inc.	ANDA	Current
70010-015	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Granules Pharmaceuticals Inc.	ANDA	Current
70010-015	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Granules Pharmaceuticals Inc.	ANDA	Current
70010-015	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Granules Pharmaceuticals Inc.	ANDA	Current
70010-015	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Granules Pharmaceuticals Inc.	ANDA	Current
70010-016	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Granules Pharmaceuticals Inc.	ANDA	Current
70010-016	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Granules Pharmaceuticals Inc.	ANDA	Current
70010-016	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Granules Pharmaceuticals Inc.	ANDA	Current
70010-016	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Granules Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84045	ORIG	2025-11-04

Application 211796

Related Records#

Application Products#

NDC Listings For This Application#

Documents#