Application 085470
- Type
- ANDA
- Sponsor
- PHARMACIA AND UPJOHN
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DEPO-ESTRADIOL | ESTRADIOL CYPIONATE | INJECTABLE;INJECTION | 1MG/ML | No | No |
| 002 | DEPO-ESTRADIOL | ESTRADIOL CYPIONATE | INJECTABLE;INJECTION | 3MG/ML | No | No |
| 003 | DEPO-ESTRADIOL | ESTRADIOL CYPIONATE | INJECTABLE;INJECTION | 5MG/ML | No | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0009-0271 | Depo-Estradiol | estradiol cypionate | Pharmacia and Upjohn Company LLC | ANDA | Current |
| 0009-0271 | Depo-Estradiol | estradiol cypionate | Pharmacia & Upjohn Company LLC | ANDA | Current |
| 0009-0271 | Depo-Estradiol | estradiol cypionate | Pharmacia and Upjohn Company LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 39588 | SUPPL | 2009-09-30 |