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Application 090065
- Type
- ANDA
- Sponsor
- EPIC PHARMA LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 002 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 42806-317 | Methadone Hydrochloride | Methadone Hydrochloride | Epic Pharma, LLC | ANDA | Current |
| 42806-317 | Methadone Hydrochloride | Methadone Hydrochloride | Epic Pharma, LLC | ANDA | Current |
| 42806-317 | Methadone Hydrochloride | Methadone Hydrochloride | Epic Pharma, LLC | ANDA | Current |
| 42806-318 | Methadone Hydrochloride | Methadone Hydrochloride | Epic Pharma, LLC | ANDA | Current |
| 42806-318 | Methadone Hydrochloride | Methadone Hydrochloride | Epic Pharma, LLC | ANDA | Current |
| 42806-318 | Methadone Hydrochloride | Methadone Hydrochloride | Epic Pharma, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 76290 | ORIG | 2023-11-03 |