Product Details for ANDA 077107
DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE HYDROCHLORIDE)
2.5MG
Marketing Status: Discontinued
5MG
Marketing Status: Discontinued
10MG
Marketing Status: Discontinued
2.5MG
Marketing Status: Discontinued
Active Ingredient: DEXMETHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A077107
Product Number: 003
Approval Date: Jan 29, 2007
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status: Discontinued
Patent and Exclusivity Information
DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE HYDROCHLORIDE)
Proprietary Name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A077107
Product Number: 003
Approval Date: Jan 29, 2007
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status: Discontinued
Patent and Exclusivity Information
5MG
Marketing Status: Discontinued
Active Ingredient: DEXMETHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A077107
Product Number: 001
Approval Date: Jan 29, 2007
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status: Discontinued
Patent and Exclusivity Information
DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE HYDROCHLORIDE)
Proprietary Name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A077107
Product Number: 001
Approval Date: Jan 29, 2007
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status: Discontinued
Patent and Exclusivity Information
10MG
Marketing Status: Discontinued
Active Ingredient: DEXMETHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A077107
Product Number: 002
Approval Date: Jan 29, 2007
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A077107
Product Number: 002
Approval Date: Jan 29, 2007
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status: Discontinued
Patent and Exclusivity Information