Application 074288
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ACEBUTOLOL HYDROCHLORIDE | ACEBUTOLOL HYDROCHLORIDE | CAPSULE;ORAL | EQ 200MG BASE | No | No |
| 002 | ACEBUTOLOL HYDROCHLORIDE | ACEBUTOLOL HYDROCHLORIDE | CAPSULE;ORAL | EQ 400MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-1200 | Acebutolol Hydrochloride | acebutolol hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1200 | Acebutolol Hydrochloride | acebutolol hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1400 | Acebutolol Hydrochloride | acebutolol hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1400 | Acebutolol Hydrochloride | acebutolol hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |