Application 078309
- Type
- ANDA
- Sponsor
- MYLAN SPECIALITY LP
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LEVALBUTEROL HYDROCHLORIDE | LEVALBUTEROL HYDROCHLORIDE | SOLUTION;INHALATION | EQ 0.25% BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0378-6993 | Levalbuterol | levalbuterol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6993 | Levalbuterol | levalbuterol | Mylan Pharmaceuticals Inc. | ANDA | Current |