Montelukast
- Product NDC
- 71610-563
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA202843
- Marketing category
- ANDA
- Substance
- MONTELUKAST SODIUM
- Current FDA listing
- Yes
Packages
| Package NDC | Description | Marketing start | Marketing end | Sample | Status |
|---|
| 71610-563-30 | 30 TABLET, FILM COATED in 1 BOTTLE (71610-563-30) | 2021-05-27 | | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Montelukast | Aphena Pharma Solutions - Tennessee, LLC | 2021-06-26 | HUMAN PRESCRIPTION DRUG LABEL | 1 |