Application 202096
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MONTELUKAST SODIUM | MONTELUKAST SODIUM | TABLET, CHEWABLE;ORAL | EQ 4MG BASE | No | No |
| 002 | MONTELUKAST SODIUM | MONTELUKAST SODIUM | TABLET, CHEWABLE;ORAL | EQ 5MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50090-2619 | Montelukast Sodium | Montelukast Sodium | A-S Medication Solutions | ANDA | Current |
| 52343-035 | Montelukast Sodium | Montelukast Sodium | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-035 | Montelukast Sodium | Montelukast Sodium | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-036 | Montelukast Sodium | Montelukast Sodium | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-036 | Montelukast Sodium | Montelukast Sodium | ACETRIS HEALTH, LLC | ANDA | Current |
| 53002-4730 | Montelukast Sodium | Montelukast Sodium | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 57237-212 | Montelukast Sodium | Montelukast Sodium | Rising Health, LLC | ANDA | Current |
| 57237-212 | Montelukast Sodium | Montelukast Sodium | Rising Health, LLC | ANDA | Current |
| 57237-212 | Montelukast Sodium | Montelukast Sodium | Rising Health, LLC | ANDA | Current |
| 57237-212 | Montelukast Sodium | Montelukast Sodium | Rising Health, LLC | ANDA | Current |
| 57237-212 | Montelukast Sodium | Montelukast Sodium | Rising Health, LLC | ANDA | Current |
| 57237-213 | Montelukast Sodium | Montelukast Sodium | Rising Health, LLC | ANDA | Current |
| 57237-213 | Montelukast Sodium | Montelukast Sodium | Rising Health, LLC | ANDA | Current |
| 57237-213 | Montelukast Sodium | Montelukast Sodium | Rising Health, LLC | ANDA | Current |
| 57237-213 | Montelukast Sodium | Montelukast Sodium | Rising Health, LLC | ANDA | Current |
| 57237-213 | Montelukast Sodium | Montelukast Sodium | Rising Health, LLC | ANDA | Current |
| 63629-4978 | Montelukast Sodium | Montelukast Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-4978 | Montelukast Sodium | Montelukast Sodium | Bryant Ranch Prepack | ANDA | Current |
| 65862-567 | Montelukast Sodium | Montelukast Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-567 | Montelukast Sodium | Montelukast Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-567 | Montelukast Sodium | Montelukast Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-567 | Montelukast Sodium | Montelukast Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-567 | Montelukast Sodium | Montelukast Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-567 | Montelukast Sodium | Montelukast Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-568 | Montelukast Sodium | Montelukast Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-568 | Montelukast Sodium | Montelukast Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-568 | Montelukast Sodium | Montelukast Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-568 | Montelukast Sodium | Montelukast Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-568 | Montelukast Sodium | Montelukast Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-568 | Montelukast Sodium | Montelukast Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 68788-6410 | Montelukast Sodium | Montelukast Sodium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 71610-026 | Montelukast Sodium | Montelukast Sodium | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-026 | Montelukast Sodium | Montelukast Sodium | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 32174 | ORIG | 2012-08-06 |