Application 206685
- Type
- ANDA
- Sponsor
- MYLAN TECHNOLOGIES
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ESTRADIOL | ESTRADIOL | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.025MG/24HR | No | No |
| 002 | ESTRADIOL | ESTRADIOL | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.0375MG/24HR | No | No |
| 003 | ESTRADIOL | ESTRADIOL | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.05MG/24HR | No | No |
| 004 | ESTRADIOL | ESTRADIOL | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.075MG/24HR | No | No |
| 005 | ESTRADIOL | ESTRADIOL | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.1MG/24HR | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0378-4619 | Estradiol | estradiol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4619 | Estradiol | estradiol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4619 | Estradiol | estradiol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4620 | Estradiol | estradiol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4620 | Estradiol | estradiol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4620 | Estradiol | estradiol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4621 | Estradiol | estradiol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4621 | Estradiol | estradiol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4621 | Estradiol | estradiol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4622 | Estradiol | estradiol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4622 | Estradiol | estradiol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4622 | Estradiol | estradiol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4623 | Estradiol | estradiol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4623 | Estradiol | estradiol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4623 | Estradiol | estradiol | Mylan Pharmaceuticals Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 55408 | ORIG | 2018-09-07 |
| 55332 | ORIG | 2018-08-27 |