Application 090635
- Type
- ANDA
- Sponsor
- THEPHARMANETWORK LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 002 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0904-6530 | Methadone Hydrochloride | Methadone Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6530 | Methadone Hydrochloride | Methadone Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 55700-882 | Methadone Hydrochloride | Methadone Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-882 | Methadone Hydrochloride | Methadone Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 63629-1027 | Methadone Hydrochloride | Methadone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1027 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1027 | Methadone Hydrochloride | Methadone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1027 | Methadone Hydrochloride | Methadone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1027 | Methadone Hydrochloride | Methadone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63739-006 | Methadone Hydrochloride | Methadone Hydrochloride | McKesson Corporation | ANDA | Current |
| 67877-116 | Methadone Hydrochloride | Methadone Hydrochloride | Ascend Laboratories, LLC | ANDA | Current |
| 67877-116 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | Ascend Laboratories, LLC | ANDA | Current |
| 67877-659 | Methadone Hydrochloride | Methadone Hydrochloride | Ascend Laboratories, LLC | ANDA | Current |
| 67877-659 | Methadone Hydrochloride | Methadone Hydrochloride | Ascend Laboratories, LLC | ANDA | Current |
| 67877-660 | Methadone Hydrochloride | Methadone Hydrochloride | Ascend Laboratories, LLC | ANDA | Current |
| 67877-660 | Methadone Hydrochloride | Methadone Hydrochloride | Ascend Laboratories, LLC | ANDA | Current |
| 68084-738 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | American Health Packaging | ANDA | Current |
| 68084-738 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | American Health Packaging | ANDA | Current |
| 68084-738 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | American Health Packaging | ANDA | Current |
| 68084-738 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | American Health Packaging | ANDA | Current |
| 71335-1360 | Methadone Hydrochloride | Methadone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1360 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 44553 | ORIG | 2015-06-30 |