Application 203752
- Type
- NDA
- Sponsor
- NOVEN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MINIVELLE | ESTRADIOL | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.0375MG/24HR | Yes | No |
| 002 | MINIVELLE | ESTRADIOL | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.075MG/24HR | Yes | No |
| 003 | MINIVELLE | ESTRADIOL | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.05MG/24HR | Yes | No |
| 004 | MINIVELLE | ESTRADIOL | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.1MG/24HR | Yes | Yes |
| 005 | MINIVELLE | ESTRADIOL | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.025MG/24HR | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68968-3410 | Estradiol | estradiol | Noven Therapeutics, LLC | NDA AUTHORIZED GENERIC | Current |
| 68968-3410 | Estradiol | estradiol | Noven Therapeutics, LLC | NDA AUTHORIZED GENERIC | Current |
| 68968-3410 | Estradiol | estradiol | Noven Therapeutics, LLC | NDA AUTHORIZED GENERIC | Current |
| 68968-3410 | Estradiol | estradiol | Noven Therapeutics, LLC | NDA AUTHORIZED GENERIC | Current |
| 68968-3425 | Estradiol | estradiol | Noven Therapeutics, LLC | NDA AUTHORIZED GENERIC | Current |
| 68968-3425 | Estradiol | estradiol | Noven Therapeutics, LLC | NDA AUTHORIZED GENERIC | Current |
| 68968-3425 | Estradiol | estradiol | Noven Therapeutics, LLC | NDA AUTHORIZED GENERIC | Current |
| 68968-3425 | Estradiol | estradiol | Noven Therapeutics, LLC | NDA AUTHORIZED GENERIC | Current |
| 68968-3437 | Estradiol | estradiol | Noven Therapeutics, LLC | NDA AUTHORIZED GENERIC | Current |
| 68968-3437 | Estradiol | estradiol | Noven Therapeutics, LLC | NDA AUTHORIZED GENERIC | Current |
| 68968-3437 | Estradiol | estradiol | Noven Therapeutics, LLC | NDA AUTHORIZED GENERIC | Current |
| 68968-3437 | Estradiol | estradiol | Noven Therapeutics, LLC | NDA AUTHORIZED GENERIC | Current |
| 68968-3450 | Estradiol | estradiol | Noven Therapeutics, LLC | NDA AUTHORIZED GENERIC | Current |
| 68968-3450 | Estradiol | estradiol | Noven Therapeutics, LLC | NDA AUTHORIZED GENERIC | Current |
| 68968-3450 | Estradiol | estradiol | Noven Therapeutics, LLC | NDA AUTHORIZED GENERIC | Current |
| 68968-3450 | Estradiol | estradiol | Noven Therapeutics, LLC | NDA AUTHORIZED GENERIC | Current |
| 68968-3475 | Estradiol | estradiol | Noven Therapeutics, LLC | NDA AUTHORIZED GENERIC | Current |
| 68968-3475 | Estradiol | estradiol | Noven Therapeutics, LLC | NDA AUTHORIZED GENERIC | Current |
| 68968-3475 | Estradiol | estradiol | Noven Therapeutics, LLC | NDA AUTHORIZED GENERIC | Current |
| 68968-3475 | Estradiol | estradiol | Noven Therapeutics, LLC | NDA AUTHORIZED GENERIC | Current |
| 68968-6610 | Minivelle | estradiol | Noven Therapeutics, LLC | NDA | Current |
| 68968-6610 | Minivelle | estradiol | Noven Therapeutics, LLC | NDA | Current |
| 68968-6610 | Minivelle | estradiol | Noven Therapeutics, LLC | NDA | Current |
| 68968-6610 | Minivelle | estradiol | Noven Therapeutics, LLC | NDA | Current |
| 68968-6610 | Minivelle | estradiol | Noven Therapeutics, LLC | NDA | Current |
| 68968-6610 | Minivelle | estradiol | Noven Therapeutics, LLC | NDA | Current |
| 68968-6610 | Minivelle | estradiol | Noven Therapeutics, LLC | NDA | Current |
| 68968-6625 | Minivelle | estradiol | Noven Therapeutics, LLC | NDA | Current |
| 68968-6625 | Minivelle | estradiol | Noven Therapeutics, LLC | NDA | Current |
| 68968-6625 | Minivelle | estradiol | Noven Therapeutics, LLC | NDA | Current |
| 68968-6625 | Minivelle | estradiol | Noven Therapeutics, LLC | NDA | Current |
| 68968-6625 | Minivelle | estradiol | Noven Therapeutics, LLC | NDA | Current |
| 68968-6625 | Minivelle | estradiol | Noven Therapeutics, LLC | NDA | Current |
| 68968-6625 | Minivelle | estradiol | Noven Therapeutics, LLC | NDA | Current |
| 68968-6637 | Minivelle | estradiol | Noven Therapeutics, LLC | NDA | Current |
| 68968-6637 | Minivelle | estradiol | Noven Therapeutics, LLC | NDA | Current |
| 68968-6637 | Minivelle | estradiol | Noven Therapeutics, LLC | NDA | Current |
| 68968-6637 | Minivelle | estradiol | Noven Therapeutics, LLC | NDA | Current |
| 68968-6637 | Minivelle | estradiol | Noven Therapeutics, LLC | NDA | Current |
| 68968-6637 | Minivelle | estradiol | Noven Therapeutics, LLC | NDA | Current |
| 68968-6637 | Minivelle | estradiol | Noven Therapeutics, LLC | NDA | Current |
| 68968-6650 | Minivelle | estradiol | Noven Therapeutics, LLC | NDA | Current |
| 68968-6650 | Minivelle | estradiol | Noven Therapeutics, LLC | NDA | Current |
| 68968-6650 | Minivelle | estradiol | Noven Therapeutics, LLC | NDA | Current |
| 68968-6650 | Minivelle | estradiol | Noven Therapeutics, LLC | NDA | Current |
| 68968-6650 | Minivelle | estradiol | Noven Therapeutics, LLC | NDA | Current |
| 68968-6650 | Minivelle | estradiol | Noven Therapeutics, LLC | NDA | Current |
| 68968-6650 | Minivelle | estradiol | Noven Therapeutics, LLC | NDA | Current |
| 68968-6675 | Minivelle | estradiol | Noven Therapeutics, LLC | NDA | Current |
| 68968-6675 | Minivelle | estradiol | Noven Therapeutics, LLC | NDA | Current |
| 68968-6675 | Minivelle | estradiol | Noven Therapeutics, LLC | NDA | Current |
| 68968-6675 | Minivelle | estradiol | Noven Therapeutics, LLC | NDA | Current |
| 68968-6675 | Minivelle | estradiol | Noven Therapeutics, LLC | NDA | Current |
| 68968-6675 | Minivelle | estradiol | Noven Therapeutics, LLC | NDA | Current |
| 68968-6675 | Minivelle | estradiol | Noven Therapeutics, LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 77573 | SUPPL | 2024-02-20 |
| 77548 | SUPPL | 2024-02-16 |
| 69955 | SUPPL | 2022-01-24 |
| 69044 | SUPPL | 2021-10-21 |
| 69043 | SUPPL | 2021-10-21 |
| 69034 | SUPPL | 2021-10-20 |
| 69033 | SUPPL | 2021-10-20 |
| 68972 | SUPPL | 2021-10-13 |
| 50279 | SUPPL | 2017-11-02 |
| 40324 | SUPPL | 2014-09-26 |
| 10247 | SUPPL | 2014-09-25 |
| 24447 | ORIG | 2013-03-28 |
| 22934 | ORIG | 2013-03-28 |
| 10246 | ORIG | 2012-11-01 |
| 19491 | ORIG | 2012-10-29 |