Orange Book product
ALBUTEROL SULFATE EQ 4MG BASE
Orange Book ANDA 211397 · ACERTIS PHARMACEUTICALS LLC · Prescription
Key facts
| Proprietary name | ALBUTEROL SULFATE |
|---|---|
| Active ingredients | ALBUTEROL SULFATE |
| Strength | EQ 4MG BASE |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA211397 |
| Applicant holder | ACERTIS PHARMACEUTICALS LLC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Oct 26, 2018 |
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.