Details for New Drug Application (NDA): 219990
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The generic ingredient in GWYN LO is ethinyl estradiol; norelgestromin. There is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norelgestromin profile page.
Summary for 219990
| Tradename: | GWYN LO |
| Applicant: | Viatris Specialty |
| Ingredient: | ethinyl estradiol; norelgestromin |
| Patents: | 0 |
Pharmacology for NDA: 219990
| Mechanism of Action | Estrogen Receptor Agonists |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYSTEM;TRANSDERMAL | Strength | 0.02MG/24HR;0.22MG/24HR | ||||
| Approval Date: | Jul 28, 2026 | TE: | RLD: | Yes | |||||
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