Application 076103
- Type
- ANDA
- Sponsor
- BAUSCH AND LOMB
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IPRATROPIUM BROMIDE | IPRATROPIUM BROMIDE | SPRAY, METERED;NASAL | 0.042MG/SPRAY | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 24208-399 | Ipratropium Bromide | Ipratropium Bromide | Bausch & Lomb Incorporated | ANDA | Current |
| 24208-399 | Ipratropium Bromide | Ipratropium Bromide | Bausch & Lomb Incorporated | ANDA | Current |
| 24208-399 | Ipratropium Bromide | Ipratropium Bromide | Bausch & Lomb Incorporated | ANDA | Current |
| 42254-355 | Ipratropium Bromide | Ipratropium Bromide | Rebel Distributors Corp | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 22536 | ORIG | 2007-09-26 |