Application 076514
- Type
- ANDA
- Sponsor
- CHARTWELL RX
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 |
|---|---|---|---|---|---|
| 0185-0040 | Midodrine HCl | Midodrine Hydrochloride | Eon Labs, Inc. | ANDA | Current |
| 0185-0043 | Midodrine HCl | Midodrine Hydrochloride | Eon Labs, Inc. | ANDA | Current |
| 0185-0149 | Midodrine HCl | Midodrine Hydrochloride | Eon Labs, Inc. | ANDA | Current |
| 21695-181 | Midodrine HCl | Midodrine Hydrochloride | Rebel Distributors Corp | ANDA | Current |
| 55154-4989 | Midodrine HCl | Midodrine Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-6847 | Midodrine HCl | Midodrine Hydrochloride | Cardinal Health | ANDA | Current |
| 63739-556 | Midodrine HCl | Midodrine Hydrochloride | McKesson Corporation | ANDA | Current |
| 68084-240 | Midodrine HCl | Midodrine Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-241 | Midodrine HCl | Midodrine Hydrochloride | American Health Packaging | ANDA | Current |