Application 202160
- Type
- ANDA
- Sponsor
- AUROLIFE PHARMA LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 002 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 15MG | No | No |
| 003 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 30MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 13107-055 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Aurolife Pharma, LLC | ANDA | Current |
| 13107-055 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Aurolife Pharma, LLC | ANDA | Current |
| 13107-056 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Aurolife Pharma, LLC | ANDA | Current |
| 13107-056 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Aurolife Pharma, LLC | ANDA | Current |
| 13107-057 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Aurolife Pharma, LLC | ANDA | Current |
| 13107-057 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Aurolife Pharma, LLC | ANDA | Current |
| 68071-2368 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 71335-1361 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1361 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 76329 | ORIG | 2023-11-03 |