Orange Book product
OMEPRAZOLE AND SODIUM BICARBONATE 40MG/PACKET;1.68GM/PACKET
Orange Book ANDA 205545 · AJANTA PHARMA LTD · Prescription
Key facts
| Proprietary name | OMEPRAZOLE AND SODIUM BICARBONATE |
|---|---|
| Active ingredients | OMEPRAZOLE, SODIUM BICARBONATE |
| Strength | 40MG/PACKET;1.68GM/PACKET |
| Dosage form | FOR SUSPENSION |
| Route | ORAL |
| Application | ANDA205545 |
| Applicant holder | AJANTA PHARMA LTD |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | Yes |
| Approval date | Jul 27, 2016 |
At a glance
- 1–9 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- No Reference listed drug
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Orange Book products
The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.