Fyavolv is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Lupin Pharmaceuticals, Inc.. The primary component is Ethinyl Estradiol; Norethindrone Acetate.
| Product ID | 68180-827_4ee645be-2e7e-480e-8714-b2466a408b4b |
| NDC | 68180-827 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Fyavolv |
| Generic Name | Norethindrone Acetate And Ethinyl Estradiol |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2016-03-15 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA204213 |
| Labeler Name | Lupin Pharmaceuticals, Inc. |
| Substance Name | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
| Active Ingredient Strength | 0 mg/1; mg/1 |
| Pharm Classes | Estrogen Receptor Agonists [MoA],Estrogen [EPC],Progesterone Congeners [CS],Progestin [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
| Marketing Start Date | 2016-03-15 |
| Marketing End Date | 2022-10-31 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA204213 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2016-03-15 |
| Marketing Category | ANDA |
| Application Number | ANDA204213 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2016-03-15 |
| Marketing Category | ANDA |
| Application Number | ANDA204213 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2016-03-15 |
| Ingredient | Strength |
|---|---|
| ETHINYL ESTRADIOL | .0025 mg/1 |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 68180-828 | Fyavolv | Fyavolv |
| 68180-827 | Fyavolv | Fyavolv |
| 0093-3122 | Jinteli | norethindrone acetate and ethinyl estradiol |
| 0555-9025 | Junel | Norethindrone Acetate and Ethinyl Estradiol |
| 0555-9027 | Junel | Norethindrone Acetate and Ethinyl Estradiol |
| 51285-127 | Loestrin | Norethindrone Acetate and Ethinyl Estradiol |
| 51285-131 | Loestrin | Norethindrone Acetate and Ethinyl Estradiol |
| 51862-007 | MICROGESTIN 1/20 | norethindrone acetate and ethinyl estradiol |
| 0378-7274 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | norethindrone acetate and ethinyl estradiol |
| 0378-7280 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | norethindrone acetate and ethinyl estradiol |
| 0378-7283 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | norethindrone acetate and ethinyl estradiol |
| 0378-7288 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | norethindrone acetate and ethinyl estradiol |
| 50090-2478 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | norethindrone acetate and ethinyl estradiol |
| 50090-3395 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | norethindrone acetate and ethinyl estradiol |
| 50102-128 | TARINA Fe 1/20 | norethindrone acetate and ethinyl estradiol |
| 21695-685 | Tilia Fe | Norethindrone Acetate and Ethinyl Estradiol |
| 0555-9032 | Tri-Legest Fe | Norethindrone Acetate and Ethinyl Estradiol |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() FYAVOLV 85830153 5041369 Live/Registered |
Lupin Limited 2013-01-23 |