Details for New Drug Application (NDA): 219990
NDA 219990 describes GWYN LO, which is a drug marketed by Viatris Specialty and is included in one NDA. It is available from one supplier. Additional details are available on the GWYN LO profile page.
The generic ingredient in GWYN LO is ethinyl estradiol; norelgestromin. There is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norelgestromin profile page.
The generic ingredient in GWYN LO is ethinyl estradiol; norelgestromin. There is one drug master file entry for this compound. Nine 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 |
Suppliers and Packaging for NDA: 219990
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GWYN LO | ethinyl estradiol; norelgestromin | SYSTEM;TRANSDERMAL | 219990 | NDA | Viatris Specialty LLC | 49502-627 | 49502-627-62 | 3 POUCH in 1 CARTON (49502-627-62) / 1 PATCH in 1 POUCH (49502-627-61) / 7 d in 1 PATCH |
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 | |||||
| Regulatory Exclusivity Expiration: | Jul 28, 2029 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
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