Orange Book product
FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER 0.4MG/ML
Orange Book ANDA 075591 · BAXTER HEALTHCARE CORP · Prescription
Key facts
| Proprietary name | FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER |
|---|---|
| Active ingredients | FAMOTIDINE |
| Strength | 0.4MG/ML |
| Dosage form | INJECTABLE |
| Route | INJECTION |
| Application | ANDA075591 |
| Applicant holder | BAXTER HEALTHCARE CORP |
| Marketing status | Prescription |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | Yes |
| Approval date | May 10, 2001 |
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.