Application 076449
- Type
- ANDA
- Sponsor
- IMPAX PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | TABLET;ORAL | 2.5MG | No | No |
| 002 | MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 003 | MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0115-4211 | MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | Impax Generics | ANDA | Current |
| 0115-4222 | MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | Impax Generics | ANDA | Current |
| 0115-4233 | MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | Impax Generics | ANDA | Current |
| 42291-616 | MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | AvKARE, Inc. | ANDA | Current |
| 68084-886 | MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | American Health Packaging | ANDA | Current |
| 68151-2958 | MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | Carilion Materials Management | ANDA | Current |