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Application 202662
- Type
- ANDA
- Sponsor
- EPIC 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 | 10MG | No | No |
| 003 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 15MG | No | No |
| 004 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 30MG | No | No |
| 005 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 20MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0904-6743 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 42806-005 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Epic Pharma, LLC | ANDA | Current |
| 42806-005 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Epic Pharma, LLC | ANDA | Current |
| 42806-005 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Epic Pharma, LLC | ANDA | Current |
| 42806-006 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Epic Pharma, LLC | ANDA | Current |
| 42806-006 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Epic Pharma, LLC | ANDA | Current |
| 42806-006 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Epic Pharma, LLC | ANDA | Current |
| 42806-007 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Epic Pharma, LLC | ANDA | Current |
| 42806-007 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Epic Pharma, LLC | ANDA | Current |
| 42806-007 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Epic Pharma, LLC | ANDA | Current |
| 42806-008 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Epic Pharma, LLC | ANDA | Current |
| 42806-008 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Epic Pharma, LLC | ANDA | Current |
| 42806-008 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Epic Pharma, LLC | ANDA | Current |
| 42806-009 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Epic Pharma, LLC | ANDA | Current |
| 42806-009 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Epic Pharma, LLC | ANDA | Current |
| 42806-009 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Epic Pharma, LLC | ANDA | Current |
| 61919-444 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 61919-444 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 61919-479 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 71335-1009 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1009 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 76330 | ORIG | 2023-11-03 |
| 40206 | ORIG | 2015-11-25 |
| 10091 | ORIG | 2015-09-24 |