Application 018692
- Type
- NDA
- Sponsor
- HOSPIRA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MARCAINE | BUPIVACAINE HYDROCHLORIDE | INJECTABLE;SPINAL | 0.75% | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0409-1761 | Marcaine Spinal | Bupivacaine Hydrochloride in Dextrose | Hospira, Inc. | NDA | Current |
| 0409-1761 | Marcaine Spinal | Bupivacaine Hydrochloride in Dextrose | Hospira, Inc. | NDA | Current |
| 0409-1761 | Marcaine Spinal | Bupivacaine Hydrochloride in Dextrose | Hospira, Inc. | NDA | Current |
| 0409-1761 | Marcaine Spinal | Bupivacaine Hydrochloride in Dextrose | Hospira, Inc. | NDA | Current |