Application 200405
- Type
- ANDA
- Sponsor
- LANNETT CO INC
Application Products#
| 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 | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42291-622 | Montelukast Sodium | Montelukast Sodium | AvKARE, Inc. | ANDA | Current |
| 42291-622 | Montelukast Sodium | Montelukast Sodium | AvKARE | ANDA | Current |
| 42291-622 | Montelukast Sodium | Montelukast Sodium | AvKARE | ANDA | Current |
| 42291-622 | Montelukast Sodium | Montelukast Sodium | AvKARE | ANDA | Current |
| 42291-622 | Montelukast Sodium | Montelukast Sodium | AvKARE, Inc. | ANDA | Current |
| 42291-623 | Montelukast Sodium | Montelukast Sodium | AvKARE, Inc. | ANDA | Current |
| 42291-623 | Montelukast Sodium | Montelukast Sodium | AvKARE, Inc. | ANDA | Current |
| 42291-623 | Montelukast Sodium | Montelukast Sodium | AvKARE | ANDA | Current |
| 42291-623 | Montelukast Sodium | Montelukast Sodium | AvKARE | ANDA | Current |
| 42291-623 | Montelukast Sodium | Montelukast Sodium | AvKARE | ANDA | Current |
| 50268-573 | Montelukast Sodium | Montelukast Sodium | AvPAK | ANDA | Current |
| 50268-573 | Montelukast Sodium | Montelukast Sodium | AvPAK | ANDA | Current |
| 50268-573 | Montelukast Sodium | Montelukast Sodium | AvPAK | ANDA | Current |
| 50268-573 | Montelukast Sodium | Montelukast Sodium | AvPAK | ANDA | Current |
| 50268-574 | Montelukast Sodium | Montelukast Sodium | AvPAK | ANDA | Current |
| 50268-574 | Montelukast Sodium | Montelukast Sodium | AvPAK | ANDA | Current |
| 50268-574 | Montelukast Sodium | Montelukast Sodium | AvPAK | ANDA | Current |
| 50268-574 | Montelukast Sodium | Montelukast Sodium | AvPAK | ANDA | Current |
| 62175-204 | Montelukast Sodium | Montelukast Sodium | Lannett Company, Inc. | ANDA | Current |
| 62175-204 | Montelukast Sodium | Montelukast Sodium | Lannett Company, Inc. | ANDA | Current |
| 62175-204 | Montelukast Sodium | Montelukast Sodium | Lannett Company, Inc. | ANDA | Current |
| 62175-204 | Montelukast Sodium | Montelukast Sodium | Lannett Company, Inc.. | ANDA | Current |
| 62175-204 | Montelukast Sodium | Montelukast Sodium | Lannett Company, Inc. | ANDA | Current |
| 62175-204 | Montelukast Sodium | Montelukast Sodium | Lannett Company, Inc. | ANDA | Current |
| 62175-204 | Montelukast Sodium | Montelukast Sodium | Lannett Company, Inc. | ANDA | Current |
| 62175-204 | Montelukast Sodium | Montelukast Sodium | Lannett Company, Inc. | ANDA | Current |
| 62175-205 | Montelukast Sodium | Montelukast Sodium | Lannett Company, Inc. | ANDA | Current |
| 62175-205 | Montelukast Sodium | Montelukast Sodium | Lannett Company, Inc. | ANDA | Current |
| 62175-205 | Montelukast Sodium | Montelukast Sodium | Lannett Company, Inc. | ANDA | Current |
| 62175-205 | Montelukast Sodium | Montelukast Sodium | Lannett Company, Inc.. | ANDA | Current |
| 62175-205 | Montelukast Sodium | Montelukast Sodium | Lannett Company, Inc. | ANDA | Current |
| 62175-205 | Montelukast Sodium | Montelukast Sodium | Lannett Company, Inc. | ANDA | Current |
| 62175-205 | Montelukast Sodium | Montelukast Sodium | Lannett Company, Inc. | ANDA | Current |
| 62175-205 | Montelukast Sodium | Montelukast Sodium | Lannett Company, Inc. | ANDA | Current |
| 63187-896 | Montelukast Sodium | Montelukast Sodium | Proficient Rx LP | ANDA | Current |
| 63187-896 | Montelukast Sodium | Montelukast Sodium | Proficient Rx LP | ANDA | Current |
| 70934-485 | Montelukast Sodium | Montelukast Sodium | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71205-189 | Montelukast Sodium | Montelukast Sodium | Proficient Rx LP | ANDA | Current |
| 71205-189 | Montelukast Sodium | Montelukast Sodium | Proficient Rx LP | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9823 | ORIG | 2012-08-06 |