Application 021840
- Type
- NDA
- Sponsor
- TEVA BRANDED PHARM
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SEASONIQUE | ETHINYL ESTRADIOL; LEVONORGESTREL | TABLET;ORAL | 0.03MG,0.01MG;0.15MG,N/A | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0093-3134 | Camrese | Levonorgestrel / Ethinyl Estradiol and Ethinyl Estradiol | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3134 | Camrese | Levonorgestrel / Ethinyl Estradiol and Ethinyl Estradiol | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3134 | Camrese | Levonorgestrel / Ethinyl Estradiol and Ethinyl Estradiol | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3134 | Camrese | Levonorgestrel / Ethinyl Estradiol and Ethinyl Estradiol | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3134 | Camrese | Levonorgestrel / Ethinyl Estradiol and Ethinyl Estradiol | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 51285-087 | Seasonique | Levonorgestrel / Ethinyl Estradiol and Ethinyl Estradiol | Teva Women's Health, Inc. | NDA | Current |
| 51285-087 | Seasonique | Levonorgestrel / Ethinyl Estradiol and Ethinyl Estradiol | Teva Women's Health, Inc. | NDA | Current |
| 51285-087 | Seasonique | Levonorgestrel / Ethinyl Estradiol and Ethinyl Estradiol | Teva Women's Health, Inc. | NDA | Current |
| 51285-087 | Seasonique | Levonorgestrel / Ethinyl Estradiol and Ethinyl Estradiol | Teva Women's Health, Inc. | NDA | Current |
| 51285-087 | Seasonique | Levonorgestrel / Ethinyl Estradiol and Ethinyl Estradiol | Teva Women's Health, Inc. | NDA | Current |
| 51285-087 | Seasonique | Levonorgestrel / Ethinyl Estradiol and Ethinyl Estradiol | Teva Women's Health, Inc. | NDA | Current |
| 51285-087 | Seasonique | Levonorgestrel / Ethinyl Estradiol and Ethinyl Estradiol | Teva Women's Health, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 73335 | SUPPL | 2023-01-30 |
| 73334 | SUPPL | 2023-01-30 |
| 73323 | SUPPL | 2023-01-30 |
| 73322 | SUPPL | 2023-01-30 |
| 70937 | SUPPL | 2022-05-03 |
| 70896 | SUPPL | 2022-05-02 |
| 49380 | SUPPL | 2017-08-15 |
| 49331 | SUPPL | 2017-08-10 |
| 28685 | SUPPL | 2010-08-09 |
| 37740 | SUPPL | 2010-07-29 |
| 42322 | ORIG | 2008-07-09 |
| 16438 | ORIG | 2006-05-26 |
| 6280 | ORIG | 2006-05-26 |