Orange Book product
TETRACYCLINE HYDROCHLORIDE 500MG
Orange Book ANDA 210674 · AMNEAL PHARMACEUTICALS OF NY LLC · Prescription
Key facts
| Proprietary name | TETRACYCLINE HYDROCHLORIDE |
|---|---|
| Active ingredients | TETRACYCLINE HYDROCHLORIDE |
| Strength | 500MG |
| Dosage form | CAPSULE |
| Route | ORAL |
| Application | ANDA210674 |
| Applicant holder | AMNEAL PHARMACEUTICALS OF NY LLC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | Yes |
| Approval date | Sep 18, 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.