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Application 050588
- Type
- NDA
- Sponsor
- TELIGENT
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CEFOTAN | CEFOTETAN DISODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | Yes | No |
| 002 | CEFOTAN | CEFOTETAN DISODIUM | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL | Yes | No |
| 003 | CEFOTAN | CEFOTETAN DISODIUM | INJECTABLE;INJECTION | EQ 10GM BASE/VIAL | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 52565-052 | Cefotan | Cefotetan Disodium | Teligent Pharma, Inc. | NDA | Current |
| 52565-053 | CEFOTAN | cefotetan disodium | Teligent Pharma, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 57692 | ORIG | 2019-02-15 |
| 47552 | SUPPL | 2017-03-14 |
| 47520 | SUPPL | 2017-03-10 |
| 39014 | SUPPL | 2004-07-01 |
| 30128 | SUPPL | 2004-07-01 |
| 17906 | SUPPL | 2004-05-28 |
| 17907 | SUPPL | 2003-07-08 |
| 7856 | SUPPL | 2003-07-06 |
| 30127 | SUPPL | 2003-03-10 |