Application 076598
- Type
- ANDA
- Sponsor
- HIKMA
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IPRATROPIUM BROMIDE | IPRATROPIUM BROMIDE | SPRAY, METERED;NASAL | 0.042MG/SPRAY | No | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0054-0046 | Ipratropium Bromide | Ipratropium Bromide | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0054-0046 | Ipratropium Bromide | Ipratropium Bromide | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0054-0046 | Ipratropium Bromide | Ipratropium Bromide | West-Ward Pharmaceuticals Corp. | ANDA | Current |
Documents
| Document | Title | Submission type | Submission no. | Date |
|---|---|---|---|---|
| 22572 | 0 | ORIG | 1 | 2007-09-24 |