Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 021706
Company: SANTARUS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZEGERID OMEPRAZOLE; SODIUM BICARBONATE 40MG/PACKET;1.68GM/PACKET FOR SUSPENSION; ORAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/21/2004 ORIG-1 Approval Type 6 - New Indication (no longer used) STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021706lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021706ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021706s000_ZegeridTOC.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/21/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021706lbl.pdf

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