Application 212184
- Type
- ANDA
- Sponsor
- GLENMARK PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | THEOPHYLLINE | THEOPHYLLINE | TABLET, EXTENDED RELEASE;ORAL | 300MG | No | No |
| 002 | THEOPHYLLINE | THEOPHYLLINE | TABLET, EXTENDED RELEASE;ORAL | 450MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 68462-721 | Theophylline | Theophylline | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-722 | Theophylline | Theophylline | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 68441 | ORIG | 2021-08-23 |
| 68026 | ORIG | 2021-07-07 |