Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for ANDA 207613

Expand all

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: A207613
Product Number: 001
Approval Date: Nov 2, 2018
Applicant Holder Full Name: THINQ PHARMA-CRO PRIVATE LTD
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: A207613
Product Number: 002
Approval Date: Nov 2, 2018
Applicant Holder Full Name: THINQ PHARMA-CRO PRIVATE LTD
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: A207613
Product Number: 003
Approval Date: Nov 2, 2018
Applicant Holder Full Name: THINQ PHARMA-CRO PRIVATE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information