# KETROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE) by Anthea Pharma Private Limited: new human prescription drug listing

**Launch Signal Score:** 75/100

| Field | Value |
|---|---|
| Product | KETROLAC TROMETHAMINE |
| Generic name | KETOROLAC TROMETHAMINE |
| NDC | 83854-021 |
| Labeler | Anthea Pharma Private Limited |
| Product type | HUMAN PRESCRIPTION DRUG |
| Approval pathway | ANDA |
| Application number | ANDA221041 |
| Dosage form | INJECTION, SOLUTION |
| Route | INTRAMUSCULAR, INTRAVENOUS |
| Active ingredients | KETOROLAC TROMETHAMINE 15 mg/mL |
| Marketing start | 2026-09-25 |
| Package configurations | 2 |

## Why this score
- Prescription or biologic product.
- New generic entry: wholesalers and GPOs re-bid contracts.
- Injectable: hospital and 503B relevance.

Source: U.S. FDA National Drug Code (NDC) Directory via openFDA (https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=83854-021). Last refreshed: 2026-11-04T18:12:05.743Z.
Listing data comes from the FDA NDC directory via openFDA; a listing is not an FDA approval or endorsement and may be updated or withdrawn. Informational only; not medical advice.