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Application 212424
- Type
- ANDA
- Sponsor
- CIPLA USA INC.
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PHYTONADIONE | PHYTONADIONE | INJECTABLE;INJECTION | 1MG/0.5ML | No | No |
| 002 | PHYTONADIONE | PHYTONADIONE | INJECTABLE;INJECTION | 10MG/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 69097-530 | Phytonadione | Phytonadione | Cipla USA Inc. | ANDA | Current |
| 69097-540 | Phytonadione | Phytonadione | Cipla USA Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 71913 | ORIG | 2022-08-26 |