Application 206369
- Type
- ANDA
- Sponsor
- WEST-WARD PHARMS INT
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | LIQUID;N/A | 100% (10ML) | No | No |
| 002 | STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | LIQUID;N/A | 100% (20ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0641-6147 | Sterile Water | WATER | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-6147 | Sterile Water | WATER | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 52584-147 | Sterile Water | Sterile Water | General Injectables and Vaccines, Inc. | ANDA | Current |
| 72572-747 | Sterile Water | WATER | Civica, Inc. | ANDA | Current |
| 72572-747 | Sterile Water | WATER | Civica, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 19720 | ORIG | 2015-10-22 |
| 32803 | ORIG | 2015-09-04 |