Application 076664
- Type
- ANDA
- Sponsor
- HIKMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IPRATROPIUM BROMIDE | IPRATROPIUM BROMIDE | SPRAY, METERED;NASAL | 0.021MG/SPRAY | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0054-0045 | Ipratropium Bromide | Ipratropium Bromide | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0054-0045 | Ipratropium Bromide | Ipratropium Bromide | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0054-0045 | Ipratropium Bromide | Ipratropium Bromide | West-Ward Pharmaceuticals Corp. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 43096 | ORIG | 2007-09-24 |