Application 076758
- Type
- ANDA
- Sponsor
- SPECGX LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 15MG | No | No |
| 002 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 30MG | No | No |
| 003 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 004 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 005 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 20MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0406-0552 | OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SpecGx LLC | ANDA | Current |
| 0406-0552 | OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SpecGx LLC | ANDA | Current |
| 0406-0552 | OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SpecGx LLC | ANDA | Current |
| 0406-0552 | OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SpecGx LLC | ANDA | Current |
| 0406-0552 | OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SpecGx LLC | ANDA | Current |
| 0406-0552 | OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SpecGx LLC | ANDA | Current |
| 0406-8510 | OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SpecGx LLC | ANDA | Current |
| 0406-8515 | OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SpecGx LLC | ANDA | Current |
| 0406-8515 | OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SpecGx LLC | ANDA | Current |
| 0406-8515 | OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SpecGx LLC | ANDA | Current |
| 0406-8515 | OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SpecGx LLC | ANDA | Current |
| 0406-8515 | OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SpecGx LLC | ANDA | Current |
| 0406-8515 | OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SpecGx LLC | ANDA | Current |
| 0406-8520 | OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SpecGx LLC | ANDA | Current |
| 0406-8530 | OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SpecGx LLC | ANDA | Current |
| 0406-8530 | OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SpecGx LLC | ANDA | Current |
| 0406-8530 | OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SpecGx LLC | ANDA | Current |
| 0406-8530 | OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SpecGx LLC | ANDA | Current |
| 0406-8530 | OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SpecGx LLC | ANDA | Current |
| 0406-8530 | OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SpecGx LLC | ANDA | Current |
| 10544-599 | OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-600 | OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | Blenheim Pharmacal, Inc. | ANDA | Current |
| 66336-135 | OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | Dispensing Solutions, Inc. | ANDA | Current |
| 66336-470 | OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | Dispensing Solutions, Inc. | ANDA | Current |
| 67296-0425 | OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 67296-0425 | OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76181 | ORIG | 2023-11-03 |