Application 079103
- Type
- ANDA
- Sponsor
- MYLAN PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MONTELUKAST SODIUM | MONTELUKAST SODIUM | TABLET;ORAL | EQ 10MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-5201 | Montelukast Sodium | montelukast sodium | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 51079-223 | Montelukast Sodium | montelukast sodium | Mylan Institutional Inc. | ANDA | Current |
| 55154-4380 | Montelukast Sodium | montelukast sodium | Cardinal Health | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9223 | ORIG | 2012-08-06 |