Application 209604
- Type
- NDA
- Sponsor
- ACCORD HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 200MG/2ML (100MG/ML) | Yes | Yes |
| 002 | GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 1GM/10ML (100MG/ML) | Yes | Yes |
| 003 | GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 1.5GM/15ML (100MG/ML) | Yes | Yes |
| 004 | GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 2GM/20ML (100MG/ML) | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16729-391 | GEMCITABINE | GEMCITABINE | Accord Healthcare Inc. | NDA | Current |
| 16729-391 | GEMCITABINE | GEMCITABINE | Accord Healthcare Inc. | NDA | Current |
| 16729-391 | GEMCITABINE | GEMCITABINE | Accord Healthcare Inc. | NDA | Current |
| 16729-419 | GEMCITABINE | GEMCITABINE | Accord Healthcare Inc. | NDA | Current |
| 16729-419 | GEMCITABINE | GEMCITABINE | Accord Healthcare Inc. | NDA | Current |
| 16729-419 | GEMCITABINE | GEMCITABINE | Accord Healthcare Inc. | NDA | Current |
| 16729-423 | GEMCITABINE | GEMCITABINE | Accord Healthcare Inc. | NDA | Current |
| 16729-423 | GEMCITABINE | GEMCITABINE | Accord Healthcare Inc. | NDA | Current |
| 16729-423 | GEMCITABINE | GEMCITABINE | Accord Healthcare Inc. | NDA | Current |
| 16729-426 | GEMCITABINE | GEMCITABINE | Accord Healthcare Inc. | NDA | Current |
| 16729-426 | GEMCITABINE | GEMCITABINE | Accord Healthcare Inc. | NDA | Current |
| 16729-426 | GEMCITABINE | GEMCITABINE | Accord Healthcare Inc. | NDA | Current |
| 68001-342 | GEMCITABINE | GEMCITABINE | BluePoint Laboratories | NDA | Current |
| 68001-342 | GEMCITABINE | GEMCITABINE | BluePoint Laboratories | NDA | Current |
| 68001-342 | GEMCITABINE | GEMCITABINE | BluePoint Laboratories | NDA | Current |
| 68001-348 | GEMCITABINE | GEMCITABINE | BluePoint Laboratories | NDA | Current |
| 68001-348 | GEMCITABINE | GEMCITABINE | BluePoint Laboratories | NDA | Current |
| 68001-348 | GEMCITABINE | GEMCITABINE | BluePoint Laboratories | NDA | Current |
| 68001-350 | GEMCITABINE | GEMCITABINE | BluePoint Laboratories | NDA | Current |
| 68001-350 | GEMCITABINE | GEMCITABINE | BluePoint Laboratories | NDA | Current |
| 68001-350 | GEMCITABINE | GEMCITABINE | BluePoint Laboratories | NDA | Current |
| 68001-359 | GEMCITABINE | GEMCITABINE | BluePoint Laboratories | NDA | Current |
| 68001-359 | GEMCITABINE | GEMCITABINE | BluePoint Laboratories | NDA | Current |
| 68001-359 | GEMCITABINE | GEMCITABINE | BluePoint Laboratories | NDA | Current |