Application 091588
- Type
- ANDA
- Sponsor
- VINTAGE PHARMS LLC
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 |
|---|
| 0603-4653 | Montelukast Sodium | montelukast sodium | Par Pharmaceutical | ANDA | Current |
| 0603-4653 | Montelukast Sodium | montelukast sodium | Par Pharmaceutical | ANDA | Current |
| 0603-4654 | Montelukast Sodium | montelukast sodium | Par Pharmaceutical | ANDA | Current |
| 0603-4654 | Montelukast Sodium | montelukast sodium | Par Pharmaceutical | ANDA | Current |
| 68788-8988 | Montelukast Sodium | montelukast sodium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-9439 | Montelukast Sodium | montelukast sodium | Preferred Pharmaceuticals, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 9344 | ORIG | 2012-08-06 |