Orange Book product
MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE 0.398GM;1.102GM
Orange Book ANDA 079247 · NOVEL LABORATORIES INC · Prescription
Key facts
| Proprietary name | MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE |
|---|---|
| Active ingredients | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS, MONOBASIC, MONOHYDRATE |
| Strength | 0.398GM;1.102GM |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA079247 |
| Applicant holder | NOVEL LABORATORIES INC |
| Marketing status | Prescription |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | Yes |
| Approval date | Dec 30, 2011 |
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.