Application 017354
- Type
- NDA
- Sponsor
- TEVA BRANDED PHARM
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LOESTRIN FE 1/20 | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | TABLET;ORAL-28 | 0.02MG;1MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 51862-012 | MICROGESTIN Fe 1/20 | norethindrone acetate and ethinyl estradiol and ferrous fumarate | Mayne Pharma Inc. | NDA AUTHORIZED GENERIC | Current |
| 51862-012 | MICROGESTIN Fe 1/20 | norethindrone acetate and ethinyl estradiol and ferrous fumarate | Mayne Pharma Inc. | NDA AUTHORIZED GENERIC | Current |
| 51862-012 | MICROGESTIN Fe 1/20 | norethindrone acetate and ethinyl estradiol and ferrous fumarate | Mayne Pharma Inc. | NDA AUTHORIZED GENERIC | Current |
| 51862-012 | MICROGESTIN Fe 1/20 | norethindrone acetate and ethinyl estradiol and ferrous fumarate | Mayne Pharma Inc. | NDA AUTHORIZED GENERIC | Current |
| 51862-012 | MICROGESTIN Fe 1/20 | norethindrone acetate and ethinyl estradiol and ferrous fumarate | Mayne Pharma Inc. | NDA AUTHORIZED GENERIC | Current |
| 51862-012 | MICROGESTIN Fe 1/20 | norethindrone acetate and ethinyl estradiol and ferrous fumarate | Mayne Pharma Inc. | NDA AUTHORIZED GENERIC | Current |
| 51862-012 | MICROGESTIN Fe 1/20 | norethindrone acetate and ethinyl estradiol and ferrous fumarate | Mayne Pharma Inc. | NDA AUTHORIZED GENERIC | Current |
| 51862-012 | MICROGESTIN Fe 1/20 | norethindrone acetate and ethinyl estradiol and ferrous fumarate | Mayne Pharma Inc. | NDA AUTHORIZED GENERIC | Current |
| 53002-1616 | MICROGESTIN Fe 1/20 | norethindrone acetate and ethinyl estradiol and ferrous fumarate | RPK Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 53002-1616 | MICROGESTIN Fe 1/20 | norethindrone acetate and ethinyl estradiol and ferrous fumarate | RPK Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 73106 | SUPPL | 2023-01-06 |
| 73096 | SUPPL | 2023-01-05 |
| 70967 | SUPPL | 2022-05-04 |
| 70878 | SUPPL | 2022-05-02 |
| 49392 | SUPPL | 2017-08-15 |
| 49334 | SUPPL | 2017-08-11 |
| 46003 | SUPPL | 2016-12-02 |
| 13109 | SUPPL | 2003-05-30 |