Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 021286

Expand all

BENICAR (OLMESARTAN MEDOXOMIL)
5MG Marketing Status: Prescription

Active Ingredient: OLMESARTAN MEDOXOMIL
Proprietary Name: BENICAR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021286
Product Number: 001
Approval Date: Apr 25, 2002
Applicant Holder Full Name: DAIICHI SANKYO INC
Marketing Status:  Prescription
Patent and Exclusivity Information

BENICAR (OLMESARTAN MEDOXOMIL)
20MG Marketing Status: Prescription

Active Ingredient: OLMESARTAN MEDOXOMIL
Proprietary Name: BENICAR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021286
Product Number: 003
Approval Date: Apr 25, 2002
Applicant Holder Full Name: DAIICHI SANKYO INC
Marketing Status:  Prescription
Patent and Exclusivity Information

BENICAR (OLMESARTAN MEDOXOMIL)
40MG Marketing Status: Prescription

Active Ingredient: OLMESARTAN MEDOXOMIL
Proprietary Name: BENICAR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 40MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021286
Product Number: 004
Approval Date: Apr 25, 2002
Applicant Holder Full Name: DAIICHI SANKYO INC
Marketing Status:  Prescription
Patent and Exclusivity Information

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English