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Application 078368
- Type
- ANDA
- Sponsor
- AM REGENT
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FOMEPIZOLE | FOMEPIZOLE | INJECTABLE;INJECTION | 1.5GM/1.5ML (1GM/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0517-0710 | fomepizole | fomepizole | American Regent, Inc. | ANDA | Current |
| 0517-0710 | fomepizole | fomepizole | American Regent, Inc. | ANDA | Current |
| 0517-0710 | fomepizole | fomepizole | American Regent, Inc. | ANDA | Current |
| 0517-0710 | fomepizole | fomepizole | American Regent, Inc. | ANDA | Current |
| 0517-0710 | fomepizole | fomepizole | American Regent, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 9150 | ORIG | 2008-01-09 |