Application 075095
- Type
- ANDA
- Sponsor
- AKORN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ETHAMBUTOL HYDROCHLORIDE | ETHAMBUTOL HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No |
| 002 | ETHAMBUTOL HYDROCHLORIDE | ETHAMBUTOL HYDROCHLORIDE | TABLET;ORAL | 400MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42806-101 | ETHAMBUTOL HYDROCHLORIDE | ETHAMBUTOL HYDROCHLORIDE | Epic Pharma, LLC | ANDA | Current |
| 42806-101 | ETHAMBUTOL HYDROCHLORIDE | ETHAMBUTOL HYDROCHLORIDE | Epic Pharma, LLC | ANDA | Current |
| 42806-101 | ETHAMBUTOL HYDROCHLORIDE | ETHAMBUTOL HYDROCHLORIDE | Epic Pharma, LLC | ANDA | Current |
| 42806-102 | ETHAMBUTOL HYDROCHLORIDE | ETHAMBUTOL HYDROCHLORIDE | Epic Pharma, LLC | ANDA | Current |
| 42806-102 | ETHAMBUTOL HYDROCHLORIDE | ETHAMBUTOL HYDROCHLORIDE | Epic Pharma, LLC | ANDA | Current |
| 42806-102 | ETHAMBUTOL HYDROCHLORIDE | ETHAMBUTOL HYDROCHLORIDE | Epic Pharma, LLC | ANDA | Current |
| 50090-3948 | Ethambutol Hydrochloride | Ethambutol Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3948 | Ethambutol Hydrochloride | Ethambutol Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 61748-011 | Ethambutol Hydrochloride | Ethambutol Hydrochloride | Versapharm Incorporated | ANDA | Current |
| 61748-011 | Ethambutol Hydrochloride | Ethambutol Hydrochloride | VersaPharm Inc. - An Akorn Company | ANDA | Current |
| 61748-014 | Ethambutol Hydrochloride | Ethambutol Hydrochloride | Versapharm Incorporated | ANDA | Current |
| 61748-014 | Ethambutol Hydrochloride | Ethambutol Hydrochloride | VersaPharm Inc. - An Akorn Company | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 30755 | ORIG | 1999-11-30 |