Product Details for ANDA 205327
METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
18MG
Marketing Status: Prescription
27MG
Marketing Status: Prescription
36MG
Marketing Status: Prescription
54MG
Marketing Status: Prescription
72MG
Marketing Status: Prescription
18MG
Marketing Status: Prescription
Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: METHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 18MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A205327
Product Number: 001
Approval Date: Jul 28, 2017
Applicant Holder Full Name: OSMOTICA PHARMACEUTICAL US LLC
Marketing Status: Prescription
Patent and Exclusivity Information
METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
Proprietary Name: METHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 18MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A205327
Product Number: 001
Approval Date: Jul 28, 2017
Applicant Holder Full Name: OSMOTICA PHARMACEUTICAL US LLC
Marketing Status: Prescription
Patent and Exclusivity Information
27MG
Marketing Status: Prescription
Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: METHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 27MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A205327
Product Number: 002
Approval Date: Jul 28, 2017
Applicant Holder Full Name: OSMOTICA PHARMACEUTICAL US LLC
Marketing Status: Prescription
Patent and Exclusivity Information
METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
Proprietary Name: METHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 27MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A205327
Product Number: 002
Approval Date: Jul 28, 2017
Applicant Holder Full Name: OSMOTICA PHARMACEUTICAL US LLC
Marketing Status: Prescription
Patent and Exclusivity Information
36MG
Marketing Status: Prescription
Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: METHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 36MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A205327
Product Number: 003
Approval Date: Jul 28, 2017
Applicant Holder Full Name: OSMOTICA PHARMACEUTICAL US LLC
Marketing Status: Prescription
Patent and Exclusivity Information
METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
Proprietary Name: METHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 36MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A205327
Product Number: 003
Approval Date: Jul 28, 2017
Applicant Holder Full Name: OSMOTICA PHARMACEUTICAL US LLC
Marketing Status: Prescription
Patent and Exclusivity Information
54MG
Marketing Status: Prescription
Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: METHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 54MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A205327
Product Number: 004
Approval Date: Jul 28, 2017
Applicant Holder Full Name: OSMOTICA PHARMACEUTICAL US LLC
Marketing Status: Prescription
Patent and Exclusivity Information
METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
Proprietary Name: METHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 54MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A205327
Product Number: 004
Approval Date: Jul 28, 2017
Applicant Holder Full Name: OSMOTICA PHARMACEUTICAL US LLC
Marketing Status: Prescription
Patent and Exclusivity Information
72MG
Marketing Status: Prescription
Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: METHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 72MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A205327
Product Number: 005
Approval Date: Jul 28, 2017
Applicant Holder Full Name: OSMOTICA PHARMACEUTICAL US LLC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: METHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 72MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A205327
Product Number: 005
Approval Date: Jul 28, 2017
Applicant Holder Full Name: OSMOTICA PHARMACEUTICAL US LLC
Marketing Status: Prescription
Patent and Exclusivity Information