Application 079235
- Type
- ANDA
- Sponsor
- SEPTODONT INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PRILOCAINE HYDROCHLORIDE | PRILOCAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 4% | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0362-9014 | Prilocaine Hydrochloride | prilocaine hydrochloride | Septodont Inc. | ANDA | Current |
| 66312-630 | Citanest Plain | prilocaine hydrochloride | Dentsply Pharmaceutical Inc. | ANDA | Current |
| 66312-630 | Citanest Plain | prilocaine hydrochloride | Dentsply Pharmaceutical Inc. | ANDA | Current |
| 66312-630 | Citanest Plain | prilocaine hydrochloride | Dentsply Pharmaceutical Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9238 | ORIG | 2010-10-04 |