Orange Book product
LACTULOSE 10GM/15ML
Orange Book ANDA 090503 · FRESENIUS KABI AUSTRIA GMBH · Prescription
Key facts
| Proprietary name | LACTULOSE |
|---|---|
| Active ingredients | LACTULOSE |
| Strength | 10GM/15ML |
| Dosage form | SOLUTION |
| Route | ORAL |
| Application | ANDA090503 |
| Applicant holder | FRESENIUS KABI AUSTRIA GMBH |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AA |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Jan 25, 2012 |
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.