Application 207042
- Type
- ANDA
- Sponsor
- EUROHLTH INTL SARL
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 |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0641-6149 | Neostigmine Methylsulfate | Neostigmine Methylsulfate | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0641-6149 | Neostigmine Methylsulfate | Neostigmine Methylsulfate | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-6149 | Neostigmine Methylsulfate | Neostigmine Methylsulfate | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-6150 | Neostigmine Methylsulfate | Neostigmine Methylsulfate | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0641-6150 | Neostigmine Methylsulfate | Neostigmine Methylsulfate | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-6150 | Neostigmine Methylsulfate | Neostigmine Methylsulfate | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 72572-462 | Neostigmine Methylsulfate | Neostigmine Methylsulfate | Civica, Inc. | ANDA | Current |
| 72572-462 | Neostigmine Methylsulfate | Neostigmine Methylsulfate | Civica, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 40579 | ORIG | 2016-02-11 |
| 10609 | ORIG | 2015-12-30 |