Product Details for NDA 019815
PROAMATINE (MIDODRINE HYDROCHLORIDE)
2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: MIDODRINE HYDROCHLORIDE
Proprietary Name: PROAMATINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N019815
Product Number: 001
Approval Date: Sep 6, 1996
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
PROAMATINE (MIDODRINE HYDROCHLORIDE)
Proprietary Name: PROAMATINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N019815
Product Number: 001
Approval Date: Sep 6, 1996
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: MIDODRINE HYDROCHLORIDE
Proprietary Name: PROAMATINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N019815
Product Number: 002
Approval Date: Sep 6, 1996
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
PROAMATINE (MIDODRINE HYDROCHLORIDE)
Proprietary Name: PROAMATINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N019815
Product Number: 002
Approval Date: Sep 6, 1996
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: MIDODRINE HYDROCHLORIDE
Proprietary Name: PROAMATINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N019815
Product Number: 003
Approval Date: Mar 20, 2002
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: PROAMATINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N019815
Product Number: 003
Approval Date: Mar 20, 2002
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information