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Application 091168
- Type
- ANDA
- Sponsor
- CIPLA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | EMTRICITABINE | EMTRICITABINE | CAPSULE;ORAL | 200MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 69097-642 | emtricitabine | emtricitabine | Cipla USA Inc. | ANDA | Current |
| 69097-642 | emtricitabine | emtricitabine | Cipla USA Inc. | ANDA | Current |
| 70518-2906 | emtricitabine | emtricitabine | REMEDYREPACK INC. | ANDA | Current |
| 70518-2906 | emtricitabine | emtricitabine | REMEDYREPACK INC. | ANDA | Current |
| 70518-2906 | emtricitabine | emtricitabine | REMEDYREPACK INC. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 55184 | ORIG | 2018-08-16 |
| 31519 | ORIG | 2011-04-01 |