Application 078092
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ALBUTEROL SULFATE | ALBUTEROL SULFATE | TABLET, EXTENDED RELEASE;ORAL | EQ 8MG BASE | No | Yes |
| 002 | ALBUTEROL SULFATE | ALBUTEROL SULFATE | TABLET, EXTENDED RELEASE;ORAL | EQ 4MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-4122 | Albuterol Sulfate | albuterol sulfate | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4122 | Albuterol Sulfate | albuterol sulfate | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4124 | Albuterol Sulfate | albuterol sulfate | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4124 | Albuterol Sulfate | albuterol sulfate | Mylan Pharmaceuticals Inc. | ANDA | Current |