Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 021849

Expand all

ZEGERID (OMEPRAZOLE; SODIUM BICARBONATE)
20MG;1.1GM
Marketing Status: Prescription
Active Ingredient: OMEPRAZOLE; SODIUM BICARBONATE
Proprietary Name: ZEGERID
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 20MG;1.1GM
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021849
Product Number: 001
Approval Date: Feb 27, 2006
Applicant Holder Full Name: SALIX PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ZEGERID (OMEPRAZOLE; SODIUM BICARBONATE)
40MG;1.1GM
Marketing Status: Prescription
Active Ingredient: OMEPRAZOLE; SODIUM BICARBONATE
Proprietary Name: ZEGERID
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 40MG;1.1GM
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021849
Product Number: 002
Approval Date: Feb 27, 2006
Applicant Holder Full Name: SALIX PHARMACEUTICALS 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