Application 210063
- Type
- NDA
- Sponsor
- TEVA PHARMS USA INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FULVESTRANT | FULVESTRANT | SOLUTION;INTRAMUSCULAR | 250MG/5ML (50MG/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0591-5019 | Fulvestrant | Fulvestrant | Actavis Pharma, Inc. | NDA | Current |
| 0591-5019 | Fulvestrant | Fulvestrant | Actavis Pharma, Inc. | NDA | Current |
| 0591-5019 | Fulvestrant | Fulvestrant | Actavis Pharma, Inc. | NDA | Current |
| 0591-5019 | Fulvestrant | Fulvestrant | Actavis Pharma, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 84331 | SUPPL | 2025-11-28 |
| 84275 | SUPPL | 2025-11-24 |
| 69311 | SUPPL | 2021-11-15 |
| 69309 | SUPPL | 2021-11-15 |
| 67027 | SUPPL | 2021-04-12 |
| 67000 | SUPPL | 2021-04-07 |
| 62137 | ORIG | 2020-03-12 |
| 59774 | ORIG | 2019-08-20 |
| 59749 | ORIG | 2019-08-20 |