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Application 020551
- Type
- NDA
- Sponsor
- ABBVIE
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | NIMBEX | CISATRACURIUM BESYLATE | INJECTABLE;INJECTION | EQ 2MG BASE/ML | Yes | Yes |
| 002 | NIMBEX PRESERVATIVE FREE | CISATRACURIUM BESYLATE | INJECTABLE;INJECTION | EQ 10MG BASE/ML | Yes | Yes |
| 003 | NIMBEX PRESERVATIVE FREE | CISATRACURIUM BESYLATE | INJECTABLE;INJECTION | EQ 2MG BASE/ML | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0074-4378 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4378 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4378 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4378 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4378 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4378 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4378 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4378 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4378 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4378 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4378 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4378 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4378 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4380 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4380 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4380 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4380 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4380 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4380 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4380 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4380 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4380 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4380 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4380 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4380 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4380 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4382 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4382 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4382 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4382 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4382 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4382 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4382 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4382 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4382 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4382 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4382 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4382 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4382 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 72388 | SUPPL | 2022-10-17 |
| 72357 | SUPPL | 2022-10-17 |
| 72287 | SUPPL | 2022-10-11 |
| 55020 | SUPPL | 2018-10-24 |
| 55040 | SUPPL | 2018-07-30 |
| 55039 | SUPPL | 2018-07-30 |
| 55019 | SUPPL | 2018-07-27 |
| 2709 | SUPPL | 2010-11-30 |
| 34814 | SUPPL | 2010-11-22 |
| 25160 | SUPPL | 2010-06-08 |
| 25159 | SUPPL | 2003-07-28 |
| 2708 | SUPPL | 2002-06-04 |