Application 203629
- Type
- NDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | SOLUTION;INTRAVENOUS | 5MG/10ML (0.5MG/ML) | No | No |
| 002 | NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | SOLUTION;INTRAVENOUS | 10MG/10ML (1MG/ML) | No | No |
| 003 | NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | SOLUTION;INTRAVENOUS | 3MG/3ML (1MG/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 52584-415 | Neostigmine Methylsulfate | Neostigmine Methylsulfate | General Injectables and Vaccines, Inc | NDA | Current |
| 63323-413 | Neostigmine Methylsulfate | Neostigmine Methylsulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-413 | Neostigmine Methylsulfate | Neostigmine Methylsulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-413 | Neostigmine Methylsulfate | Neostigmine Methylsulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-413 | Neostigmine Methylsulfate | Neostigmine Methylsulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-413 | Neostigmine Methylsulfate | Neostigmine Methylsulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-413 | Neostigmine Methylsulfate | Neostigmine Methylsulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-415 | Neostigmine Methylsulfate | Neostigmine Methylsulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-415 | Neostigmine Methylsulfate | Neostigmine Methylsulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-415 | Neostigmine Methylsulfate | Neostigmine Methylsulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-415 | Neostigmine Methylsulfate | Neostigmine Methylsulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-415 | Neostigmine Methylsulfate | Neostigmine Methylsulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-415 | Neostigmine Methylsulfate | Neostigmine Methylsulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 65219-811 | Neostigmine Methylsulfate | Neostigmine Methylsulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-214 | Neostigmine Methylsulfate | Neostigmine Methylsulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-383 | Neostigmine Methylsulfate | Neostigmine Methylsulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-383 | Neostigmine Methylsulfate | Neostigmine Methylsulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-383 | Neostigmine Methylsulfate | Neostigmine Methylsulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-383 | Neostigmine Methylsulfate | Neostigmine Methylsulfate | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-383 | Neostigmine Methylsulfate | Neostigmine Methylsulfate | Fresenius Kabi USA, LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 66118 | SUPPL | 2021-02-08 |
| 66116 | SUPPL | 2021-02-05 |
| 44887 | ORIG | 2015-07-22 |
| 22929 | ORIG | 2015-07-22 |
| 40316 | ORIG | 2015-01-29 |
| 10241 | ORIG | 2015-01-13 |