Product Details for ANDA 076725
ORVATEN (MIDODRINE HYDROCHLORIDE)
2.5MG
Marketing Status: Prescription
5MG
Marketing Status: Prescription
10MG
Marketing Status: Prescription
2.5MG
Marketing Status: Prescription
Active Ingredient: MIDODRINE HYDROCHLORIDE
Proprietary Name: ORVATEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076725
Product Number: 001
Approval Date: Nov 3, 2004
Applicant Holder Full Name: UPSHER SMITH LABORATORIES LLC
Marketing Status: Prescription
Patent and Exclusivity Information
ORVATEN (MIDODRINE HYDROCHLORIDE)
Proprietary Name: ORVATEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076725
Product Number: 001
Approval Date: Nov 3, 2004
Applicant Holder Full Name: UPSHER SMITH LABORATORIES LLC
Marketing Status: Prescription
Patent and Exclusivity Information
5MG
Marketing Status: Prescription
Active Ingredient: MIDODRINE HYDROCHLORIDE
Proprietary Name: ORVATEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A076725
Product Number: 002
Approval Date: Nov 3, 2004
Applicant Holder Full Name: UPSHER SMITH LABORATORIES LLC
Marketing Status: Prescription
Patent and Exclusivity Information
ORVATEN (MIDODRINE HYDROCHLORIDE)
Proprietary Name: ORVATEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A076725
Product Number: 002
Approval Date: Nov 3, 2004
Applicant Holder Full Name: UPSHER SMITH LABORATORIES LLC
Marketing Status: Prescription
Patent and Exclusivity Information
10MG
Marketing Status: Prescription
Active Ingredient: MIDODRINE HYDROCHLORIDE
Proprietary Name: ORVATEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076725
Product Number: 003
Approval Date: Nov 3, 2004
Applicant Holder Full Name: UPSHER SMITH LABORATORIES LLC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: ORVATEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076725
Product Number: 003
Approval Date: Nov 3, 2004
Applicant Holder Full Name: UPSHER SMITH LABORATORIES LLC
Marketing Status: Prescription
Patent and Exclusivity Information