Application 212429
- 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 | SOLUTION;ORAL | 5MG/5ML | No | No |
| 002 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | SOLUTION;ORAL | 100MG/5ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 13107-261 | Oxycodone Hydrochloride Oral Solution | Oxycodone Hydrochloride Oral Solution | Aurolife Pharma, LLC | ANDA | Current |
| 13107-262 | Oxycodone Hydrochloride Oral Solution | Oxycodone Hydrochloride Oral Solution | Aurolife Pharma, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 76470 | ORIG | 2023-11-07 |