Application 091488
- Type
- ANDA
- Sponsor
- MEITHEAL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ATRACURIUM BESYLATE PRESERVATIVE FREE | ATRACURIUM BESYLATE | INJECTABLE;INJECTION | 10MG/ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 25021-659 | Atracurium Besylate | atracurium besylate | Sagent Pharmaceuticals | ANDA | Current |
| 25021-659 | Atracurium Besylate | atracurium besylate | Sagent Pharmaceuticals | ANDA | Current |
| 25021-659 | Atracurium Besylate | atracurium besylate | Sagent Pharmaceuticals | ANDA | Current |
| 25021-659 | Atracurium Besylate | atracurium besylate | Sagent Pharmaceuticals | ANDA | Current |
| 25021-659 | Atracurium Besylate | atracurium besylate | Sagent Pharmaceuticals | ANDA | Current |
| 71288-701 | Atracurium Besylate | Atracurium Besylate | Meitheal Pharmaceuticals Inc. | ANDA | Current |
| 71288-701 | Atracurium Besylate | Atracurium Besylate | Meitheal Pharmaceuticals Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 22727 | ORIG | 2012-09-12 |