Application 078907
- Type
- ANDA
- Sponsor
- SPECGX LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FENTANYL CITRATE | FENTANYL CITRATE | TROCHE/LOZENGE;TRANSMUCOSAL | EQ 0.2MG BASE | No | No |
| 002 | FENTANYL CITRATE | FENTANYL CITRATE | TROCHE/LOZENGE;TRANSMUCOSAL | EQ 0.4MG BASE | No | No |
| 003 | FENTANYL CITRATE | FENTANYL CITRATE | TROCHE/LOZENGE;TRANSMUCOSAL | EQ 0.6MG BASE | No | No |
| 004 | FENTANYL CITRATE | FENTANYL CITRATE | TROCHE/LOZENGE;TRANSMUCOSAL | EQ 0.8MG BASE | No | No |
| 005 | FENTANYL CITRATE | FENTANYL CITRATE | TROCHE/LOZENGE;TRANSMUCOSAL | EQ 1.2MG BASE | No | No |
| 006 | FENTANYL CITRATE | FENTANYL CITRATE | TROCHE/LOZENGE;TRANSMUCOSAL | EQ 1.6MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0406-9202 | FENTANYL CITRATE | FENTANYL CITRATE | SpecGx LLC | ANDA | Current |
| 0406-9202 | FENTANYL CITRATE | FENTANYL CITRATE | SpecGx LLC | ANDA | Current |
| 0406-9202 | FENTANYL CITRATE | FENTANYL CITRATE | SpecGx LLC | ANDA | Current |
| 0406-9202 | FENTANYL CITRATE | FENTANYL CITRATE | SpecGx LLC | ANDA | Current |
| 0406-9202 | FENTANYL CITRATE | FENTANYL CITRATE | SpecGx LLC | ANDA | Current |
| 0406-9204 | FENTANYL CITRATE | FENTANYL CITRATE | SpecGx LLC | ANDA | Current |
| 0406-9204 | FENTANYL CITRATE | FENTANYL CITRATE | SpecGx LLC | ANDA | Current |
| 0406-9204 | FENTANYL CITRATE | FENTANYL CITRATE | SpecGx LLC | ANDA | Current |
| 0406-9204 | FENTANYL CITRATE | FENTANYL CITRATE | SpecGx LLC | ANDA | Current |
| 0406-9204 | FENTANYL CITRATE | FENTANYL CITRATE | SpecGx LLC | ANDA | Current |
| 0406-9206 | FENTANYL CITRATE | FENTANYL CITRATE | SpecGx LLC | ANDA | Current |
| 0406-9206 | FENTANYL CITRATE | FENTANYL CITRATE | SpecGx LLC | ANDA | Current |
| 0406-9206 | FENTANYL CITRATE | FENTANYL CITRATE | SpecGx LLC | ANDA | Current |
| 0406-9206 | FENTANYL CITRATE | FENTANYL CITRATE | SpecGx LLC | ANDA | Current |
| 0406-9206 | FENTANYL CITRATE | FENTANYL CITRATE | SpecGx LLC | ANDA | Current |
| 0406-9208 | FENTANYL CITRATE | FENTANYL CITRATE | SpecGx LLC | ANDA | Current |
| 0406-9208 | FENTANYL CITRATE | FENTANYL CITRATE | SpecGx LLC | ANDA | Current |
| 0406-9208 | FENTANYL CITRATE | FENTANYL CITRATE | SpecGx LLC | ANDA | Current |
| 0406-9208 | FENTANYL CITRATE | FENTANYL CITRATE | SpecGx LLC | ANDA | Current |
| 0406-9208 | FENTANYL CITRATE | FENTANYL CITRATE | SpecGx LLC | ANDA | Current |
| 0406-9212 | FENTANYL CITRATE | FENTANYL CITRATE | SpecGx LLC | ANDA | Current |
| 0406-9212 | FENTANYL CITRATE | FENTANYL CITRATE | SpecGx LLC | ANDA | Current |
| 0406-9212 | FENTANYL CITRATE | FENTANYL CITRATE | SpecGx LLC | ANDA | Current |
| 0406-9212 | FENTANYL CITRATE | FENTANYL CITRATE | SpecGx LLC | ANDA | Current |
| 0406-9212 | FENTANYL CITRATE | FENTANYL CITRATE | SpecGx LLC | ANDA | Current |
| 0406-9216 | FENTANYL CITRATE | FENTANYL CITRATE | SpecGx LLC | ANDA | Current |
| 0406-9216 | FENTANYL CITRATE | FENTANYL CITRATE | SpecGx LLC | ANDA | Current |
| 0406-9216 | FENTANYL CITRATE | FENTANYL CITRATE | SpecGx LLC | ANDA | Current |
| 0406-9216 | FENTANYL CITRATE | FENTANYL CITRATE | SpecGx LLC | ANDA | Current |
| 0406-9216 | FENTANYL CITRATE | FENTANYL CITRATE | SpecGx LLC | ANDA | Current |