Application 071427
- Type
- ANDA
- Sponsor
- SANDOZ
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TEMAZEPAM | TEMAZEPAM | CAPSULE;ORAL | 15MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0615-7808 | Temazepam | Temazepam | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0781-2201 | Temazepam | Temazepam | Sandoz Inc | ANDA | Current |
| 0781-2201 | Temazepam | Temazepam | Sandoz Inc | ANDA | Current |
| 63739-231 | Temazepam | Temazepam | McKesson Packaging Services a business unit of McKesson Corporation | ANDA | Current |
| 63739-231 | Temazepam | Temazepam | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 67544-038 | Temazepam | Temazepam | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |