Application 203502
- Type
- ANDA
- Sponsor
- AUROLIFE 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 |
|---|
| 13107-088 | Methadone Hydrochloride | Methadone Hydrochloride | Aurolife Pharma, LLC | ANDA | Current |
| 13107-088 | Methadone Hydrochloride | Methadone Hydrochloride | Aurolife Pharma, LLC | ANDA | Current |
| 13107-088 | Methadone Hydrochloride | Methadone Hydrochloride | Aurolife Pharma, LLC | ANDA | Current |
| 13107-088 | Methadone Hydrochloride | Methadone Hydrochloride | Aurolife Pharma, LLC | ANDA | Current |
| 13107-088 | Methadone Hydrochloride | Methadone Hydrochloride | Aurolife Pharma, LLC | ANDA | Current |
| 13107-089 | Methadone Hydrochloride | Methadone Hydrochloride | Aurolife Pharma, LLC | ANDA | Current |
| 13107-089 | Methadone Hydrochloride | Methadone Hydrochloride | Aurolife Pharma, LLC | ANDA | Current |
| 13107-089 | Methadone Hydrochloride | Methadone Hydrochloride | Aurolife Pharma, LLC | ANDA | Current |
| 13107-089 | Methadone Hydrochloride | Methadone Hydrochloride | Aurolife Pharma, LLC | ANDA | Current |
| 13107-089 | Methadone Hydrochloride | Methadone Hydrochloride | Aurolife Pharma, LLC | ANDA | Current |
| 60687-214 | Methadone Hydrochloride | Methadone Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-214 | Methadone Hydrochloride | Methadone Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-214 | Methadone Hydrochloride | Methadone Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-214 | Methadone Hydrochloride | Methadone Hydrochloride | American Health Packaging | ANDA | Current |
| 71335-0493 | Methadone Hydrochloride | Methadone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0493 | Methadone Hydrochloride | Methadone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0493 | Methadone Hydrochloride | Methadone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0735 | Methadone Hydrochloride | Methadone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0735 | Methadone Hydrochloride | Methadone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 76291 | ORIG | 2023-11-03 |