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Application 064144
- Type
- ANDA
- Sponsor
- ACCORD HLTHCARE
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MITOMYCIN | MITOMYCIN | INJECTABLE;INJECTION | 5MG/VIAL | No | Yes |
| 002 | MITOMYCIN | MITOMYCIN | INJECTABLE;INJECTION | 20MG/VIAL | No | Yes |
| 003 | MITOMYCIN | MITOMYCIN | INJECTABLE;INJECTION | 40MG/VIAL | No | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16729-108 | Mitomycin | Mitomycin | Accord Healthcare Inc | ANDA | Current |
| 16729-108 | Mitomycin | Mitomycin | Accord Healthcare Inc | ANDA | Current |
| 16729-108 | Mitomycin | Mitomycin | Accord Healthcare Inc | ANDA | Current |
| 16729-115 | Mitomycin | Mitomycin | Accord Healthcare Inc | ANDA | Current |
| 16729-115 | Mitomycin | Mitomycin | Accord Healthcare Inc | ANDA | Current |
| 16729-115 | Mitomycin | Mitomycin | Accord Healthcare Inc | ANDA | Current |
| 16729-116 | Mitomycin | Mitomycin | Accord Healthcare Inc | ANDA | Current |
| 16729-116 | Mitomycin | Mitomycin | Accord Healthcare Inc | ANDA | Current |
| 16729-116 | Mitomycin | Mitomycin | Accord Healthcare Inc | ANDA | Current |
| 16729-246 | Mitomycin | Mitomycin | Accord Healthcare Inc | ANDA | Current |
| 16729-246 | Mitomycin | Mitomycin | Accord Healthcare Inc | ANDA | Current |
| 16729-246 | Mitomycin | Mitomycin | Accord Healthcare Inc | ANDA | Current |
| 16729-247 | Mitomycin | Mitomycin | Accord Healthcare Inc | ANDA | Current |
| 16729-247 | Mitomycin | Mitomycin | Accord Healthcare Inc | ANDA | Current |
| 16729-247 | Mitomycin | Mitomycin | Accord Healthcare Inc | ANDA | Current |
| 16729-248 | Mitomycin | Mitomycin | Accord Healthcare Inc | ANDA | Current |
| 16729-248 | Mitomycin | Mitomycin | Accord Healthcare Inc | ANDA | Current |
| 16729-248 | Mitomycin | Mitomycin | Accord Healthcare Inc | ANDA | Current |
| 68001-389 | Mitomycin | Mitomycin | BluePoint Laboratories | ANDA | Current |
| 68001-389 | Mitomycin | Mitomycin | BluePoint Laboratories | ANDA | Current |
| 68001-390 | Mitomycin | Mitomycin | BluePoint Laboratories | ANDA | Current |
| 68001-390 | Mitomycin | Mitomycin | BluePoint Laboratories | ANDA | Current |
| 68001-391 | Mitomycin | Mitomycin | BluePoint Laboratories | ANDA | Current |
| 68001-391 | Mitomycin | Mitomycin | BluePoint Laboratories | ANDA | Current |
| 69448-001 | MUTAMYCIN | Mitomycin | Accord BioPharma Inc. | ANDA | Current |
| 69448-002 | MUTAMYCIN | Mitomycin | Accord BioPharma Inc. | ANDA | Current |
| 69448-003 | MUTAMYCIN | Mitomycin | Accord BioPharma Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 30618 | ORIG | 1998-04-30 |