Orange Book product
SODIUM BICARBONATE 44.6MEQ/50ML (0.9MEQ/ML)
Orange Book ANDA 211091 · EXELA PHARMA SCIENCES LLC · Prescription
Key facts
| Proprietary name | SODIUM BICARBONATE |
|---|---|
| Active ingredients | SODIUM BICARBONATE |
| Strength | 44.6MEQ/50ML (0.9MEQ/ML) |
| Dosage form | SOLUTION |
| Route | INTRAVENOUS |
| Application | ANDA211091 |
| Applicant holder | EXELA PHARMA SCIENCES LLC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AP |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | Yes |
| Approval date | Jun 20, 2019 |
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.