Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 211796

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METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
10MG
Marketing Status: Prescription

Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: METHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A211796
Product Number: 001
Approval Date: May 23, 2019
Applicant Holder Full Name: GRANULES PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
20MG
Marketing Status: Prescription

Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: METHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A211796
Product Number: 002
Approval Date: May 23, 2019
Applicant Holder Full Name: GRANULES PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
30MG
Marketing Status: Prescription

Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: METHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A211796
Product Number: 003
Approval Date: May 23, 2019
Applicant Holder Full Name: GRANULES PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
40MG
Marketing Status: Prescription

Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: METHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 40MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A211796
Product Number: 004
Approval Date: May 23, 2019
Applicant Holder Full Name: GRANULES PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
60MG
Marketing Status: Prescription

Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: METHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 60MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A211796
Product Number: 005
Approval Date: May 23, 2019
Applicant Holder Full Name: GRANULES PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information