Application 075282
- Type
- ANDA
- Sponsor
- SANDOZ INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CROMOLYN SODIUM | CROMOLYN SODIUM | SOLUTION/DROPS;OPHTHALMIC | 4% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50090-1202 | Cromolyn Sodium | Cromolyn Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-1202 | Cromolyn Sodium | Cromolyn Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-1202 | Cromolyn Sodium | Cromolyn Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-1202 | Cromolyn Sodium | Cromolyn Sodium | A-S Medication Solutions | ANDA | Current |
| 53002-0140 | Cromolyn Sodium | Cromolyn Sodium | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 61314-237 | Cromolyn Sodium | Cromolyn Sodium | Sandoz Inc | ANDA | Current |
| 61314-237 | Cromolyn Sodium | Cromolyn Sodium | Sandoz Inc | ANDA | Current |
| 61314-237 | Cromolyn Sodium | Cromolyn Sodium | Sandoz Inc | ANDA | Current |
| 71205-230 | Cromolyn Sodium | Cromolyn Sodium | Proficient Rx LP | ANDA | Current |
| 71205-230 | Cromolyn Sodium | Cromolyn Sodium | Proficient Rx LP | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8597 | ORIG | 1999-06-16 |