Application 020479
- Type
- NDA
- Sponsor
- MYLAN SPECIALITY LP
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | GASTROCROM | CROMOLYN SODIUM | CONCENTRATE;ORAL | 100MG/5ML | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0037-0678 | Gastrocrom | cromolyn sodium | Meda Pharmaceuticals | NDA | Current |
| 0037-0678 | Gastrocrom | cromolyn sodium | MEDA Pharmaceuticals | NDA | Current |
| 0037-0678 | Gastrocrom | cromolyn sodium | Meda Pharmaceuticals | NDA | Current |
| 51525-0470 | cromolyn sodium | cromolyn sodium | Wallace Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 51525-0470 | cromolyn sodium | cromolyn sodium | Wallace Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 51525-0470 | cromolyn sodium | cromolyn sodium | Wallace Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 51525-0470 | cromolyn sodium | cromolyn sodium | Wallace Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 2583 | SUPPL | 2004-06-04 |