Application 202946
- Type
- ANDA
- Sponsor
- SPECGX LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 5MG | No | No |
| 002 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 7.5MG | No | No |
| 003 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 10MG | No | No |
| 004 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 15MG | No | No |
| 005 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 20MG | No | No |
| 006 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 30MG | No | No |
| 007 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 40MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0406-8091 | Oxymorphone Hydrochloride | Oxymorphone Hydrochloride | SpecGx LLC | ANDA | Current |
| 0406-8092 | Oxymorphone Hydrochloride | Oxymorphone Hydrochloride | SpecGx LLC | ANDA | Current |
| 0406-8093 | Oxymorphone Hydrochloride | Oxymorphone Hydrochloride | SpecGx LLC | ANDA | Current |
| 0406-8094 | Oxymorphone Hydrochloride | Oxymorphone Hydrochloride | SpecGx LLC | ANDA | Current |
| 0406-8095 | Oxymorphone Hydrochloride | Oxymorphone Hydrochloride | SpecGx LLC | ANDA | Current |
| 0406-8096 | Oxymorphone Hydrochloride | Oxymorphone Hydrochloride | SpecGx LLC | ANDA | Current |
| 0406-8097 | Oxymorphone Hydrochloride | Oxymorphone Hydrochloride | SpecGx LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 24109 | ORIG | 2015-06-30 |