Application 201195
- Type
- NDA
- Sponsor
- ACCORD HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DOCETAXEL | DOCETAXEL | INJECTABLE;INJECTION | 20MG/0.5ML (40MG/ML) | Yes | No |
| 002 | DOCETAXEL | DOCETAXEL | INJECTABLE;INJECTION | 80MG/2ML (40MG/ML) | Yes | No |
| 003 | DOCETAXEL | DOCETAXEL | INJECTABLE;INJECTION | 20MG/ML (20MG/ML) | Yes | No |
| 004 | DOCETAXEL | DOCETAXEL | INJECTABLE;INJECTION | 80MG/4ML (20MG/ML) | Yes | No |
| 005 | DOCETAXEL | DOCETAXEL | INJECTABLE;INJECTION | 160MG/8ML (20MG/ML) | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16729-231 | Docetaxel | Docetaxel | Accord Healthcare Inc. | NDA | Current |
| 16729-267 | Docetaxel | Docetaxel | Accord Healthcare Inc. | NDA | Current |
| 16729-267 | DOCETAXEL | docetaxel | Accord Healthcare Inc. | NDA | Current |
| 16729-267 | DOCETAXEL | docetaxel | Accord Healthcare Inc. | NDA | Current |
| 16729-267 | DOCETAXEL | docetaxel | Accord Healthcare Inc. | NDA | Current |
| 63739-932 | Docetaxel | Docetaxel | McKesson Packaging Services a business unit of McKesson Corporation | NDA | Current |
| 63739-971 | Docetaxel | Docetaxel | McKesson Packaging Services a business unit of McKesson Corporation | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 75529 | SUPPL | 2023-09-21 |
| 75524 | SUPPL | 2023-09-21 |
| 64007 | SUPPL | 2020-07-22 |
| 63979 | SUPPL | 2020-07-21 |
| 59176 | SUPPL | 2019-06-27 |
| 59162 | SUPPL | 2019-06-24 |
| 32088 | SUPPL | 2016-07-28 |
| 40053 | SUPPL | 2016-07-27 |
| 40052 | SUPPL | 2014-07-08 |
| 32087 | SUPPL | 2014-07-08 |
| 18996 | SUPPL | 2013-04-09 |
| 43360 | ORIG | 2012-02-10 |
| 24389 | ORIG | 2012-02-10 |
| 9865 | ORIG | 2011-06-13 |
| 18995 | ORIG | 2011-06-10 |