Overview
Norelgestromin is a drug used in contraception. Norelgestromin is the active progestin responsible for the progestational activity that occurs in women after application of ORTHO EVRA patch.
Background
Norelgestromin is a drug used in contraception. Norelgestromin is the active progestin responsible for the progestational activity that occurs in women after application of ORTHO EVRA patch.
Indication
Norelgestromin is used for contraception and menopausal hormonal therapy. Norelgestromin may potentially be used in breast cancer treatment due to its inhibitory effect on estrone sulfatase . They convert sulfated steroid precursors to estrogen during pregnancy.
Associated Conditions
- Polycystic Ovarian Syndrome (PCOS)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2019/07/12 | Phase 1 | Completed | |||
2017/09/06 | Phase 4 | Completed | |||
2007/02/26 | Phase 2 | UNKNOWN | |||
2005/12/05 | Phase 4 | Completed | Janssen Pharmaceutica N.V., Belgium | ||
2005/11/24 | Phase 1 | Completed | |||
2005/11/24 | Phase 1 | Completed | |||
2005/11/17 | Phase 1 | Completed | |||
2005/10/12 | Phase 3 | Completed | |||
2005/10/12 | Phase 3 | Completed | |||
2005/10/12 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Bryant Ranch Prepack | 72162-2220 | TRANSDERMAL | 150 ug in 1 d | 1/5/2024 | |
| Zydus Pharmaceuticals USA Inc. | 70710-1190 | TRANSDERMAL | 150 ug in 1 mg | 9/16/2023 | |
| Zydus Lifesciences Limited | 70771-1777 | TRANSDERMAL | 150 ug in 1 mg | 9/16/2023 | |
| Mylan Pharmaceuticals Inc. | 0378-3340 | TRANSDERMAL | 150 ug in 1 d | 2/4/2021 | |
| Amneal Pharmaceuticals NY LLC | 69238-1521 | TRANSDERMAL | 150 ug in 1 d | 12/30/2023 | |
| AvKARE | 42291-930 | TRANSDERMAL | 150 ug in 1 d | 5/15/2023 | |
| Amneal Pharmaceuticals LLC | 65162-358 | TRANSDERMAL | 150 ug in 1 d | 5/1/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 8/22/2002 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| EVRA TRANSDERMAL PATCH (6 mg/600 mcg) | SIN12423P | PATCH | 6 mg/patch | 9/17/2003 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||