Orange Book product
METFORMIN HYDROCHLORIDE 500MG
Orange Book ANDA 090888 · MARKSANS PHARMA LTD · Prescription
Key facts
| Proprietary name | METFORMIN HYDROCHLORIDE |
|---|---|
| Active ingredients | METFORMIN HYDROCHLORIDE |
| Strength | 500MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA090888 |
| Applicant holder | MARKSANS PHARMA LTD |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Mar 12, 2012 |
At a glance
- 10–99 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.