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Application 009165
- Type
- NDA
- Sponsor
- ENDO PHARMS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DELATESTRYL | TESTOSTERONE ENANTHATE | INJECTABLE;INJECTION | 200MG/ML | No | No |
| 003 | DELATESTRYL | TESTOSTERONE ENANTHATE | INJECTABLE;INJECTION | 200MG/ML | Yes | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 45745 | SUPPL | 2016-11-01 |
| 45670 | SUPPL | 2016-10-27 |
| 32986 | SUPPL | 2015-05-13 |
| 11863 | SUPPL | 2015-05-13 |
| 10718 | SUPPL | 2014-06-23 |
| 126 | SUPPL | 2014-06-23 |
| 125 | SUPPL | 2007-07-30 |
| 32985 | SUPPL | 2007-07-27 |
| 32984 | SUPPL | 2007-03-15 |
| 11862 | SUPPL | 2007-03-15 |