Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 076577

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MIDODRINE HYDROCHLORIDE (MIDODRINE HYDROCHLORIDE)
2.5MG
Marketing Status: Prescription

Active Ingredient: MIDODRINE HYDROCHLORIDE
Proprietary Name: MIDODRINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076577
Product Number: 001
Approval Date: Sep 10, 2003
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

MIDODRINE HYDROCHLORIDE (MIDODRINE HYDROCHLORIDE)
5MG
Marketing Status: Prescription

Active Ingredient: MIDODRINE HYDROCHLORIDE
Proprietary Name: MIDODRINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076577
Product Number: 002
Approval Date: Sep 10, 2003
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: MIDODRINE HYDROCHLORIDE
Proprietary Name: MIDODRINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076577
Product Number: 003
Approval Date: Sep 10, 2003
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information