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Application 076156
- Type
- ANDA
- Sponsor
- APOTEX INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | IPRATROPIUM BROMIDE | IPRATROPIUM BROMIDE | SPRAY, METERED;NASAL | 0.021MG/SPRAY | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16714-526 | Ipratropium Bromide | Ipratropium Bromide | NORTHSTAR RX LLC | ANDA | Current |
| 60505-0826 | Ipratropium Bromide | Ipratropium Bromide | Apotex Corp. | ANDA | Current |
| 60505-0826 | Ipratropium Bromide | Ipratropium Bromide | Apotex Corp. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 22540 | ORIG | 2005-07-22 |