Application 200154
- Type
- ANDA
- Sponsor
- SANDOZ INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CISATRACURIUM BESYLATE PRESERVATIVE FREE | CISATRACURIUM BESYLATE | INJECTABLE;INJECTION | EQ 2MG BASE/ML | No | No |
| 002 | CISATRACURIUM BESYLATE PRESERVATIVE FREE | CISATRACURIUM BESYLATE | INJECTABLE;INJECTION | EQ 10MG BASE/ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0781-3150 | cisatracurium besylate | cisatracurium besylate | Sandoz Inc | ANDA | Current |
| 0781-3150 | cisatracurium besylate | cisatracurium besylate | Sandoz Inc | ANDA | Current |
| 0781-3150 | cisatracurium besylate | cisatracurium besylate | Sandoz Inc | ANDA | Current |
| 0781-3150 | cisatracurium besylate | cisatracurium besylate | Sandoz Inc | ANDA | Current |
| 0781-3153 | cisatracurium besylate | cisatracurium besylate | Sandoz Inc | ANDA | Current |
| 0781-3153 | cisatracurium besylate | cisatracurium besylate | Sandoz Inc | ANDA | Current |
| 0781-3153 | cisatracurium besylate | cisatracurium besylate | Sandoz Inc | ANDA | Current |
| 0781-3153 | cisatracurium besylate | cisatracurium besylate | Sandoz Inc | ANDA | Current |
| 0781-9037 | cisatracurium besylate | cisatracurium besylate | Sandoz Inc | ANDA | Current |
| 0781-9037 | cisatracurium besylate | cisatracurium besylate | Sandoz Inc | ANDA | Current |
| 0781-9037 | cisatracurium besylate | cisatracurium besylate | Sandoz Inc | ANDA | Current |
| 0781-9039 | cisatracurium besylate | cisatracurium besylate | Sandoz Inc | ANDA | Current |
| 0781-9039 | cisatracurium besylate | cisatracurium besylate | Sandoz Inc | ANDA | Current |
| 0781-9039 | cisatracurium besylate | cisatracurium besylate | Sandoz Inc | ANDA | Current |
| 72572-067 | cisatracurium besylate | cisatracurium besylate | Civica, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 22828 | ORIG | 2012-09-12 |