GWYN LO
VIATRIS SPECIALTY · ETHINYL ESTRADIOL, NORELGESTROMIN
Open FDA's page for this record- Application number
- NDA219990
- Sponsor name
- VIATRIS SPECIALTY
- Submissions
- Submission type
- ORIG
- Submission number
- 1
- Submission status
- AP
- Submission status date
- 20260728
- Review priority
- STANDARD
- Submission class code
- TYPE 5
- Submission class code description
- Type 5 - New Formulation or New Manufacturer
- Application docs
- ID
- 86759
- Url
- https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/219990Orig1s000ltr.pdf
- Date
- 20260730
- Type
- Letter
- Products
- Product number
- 001
- Reference drug
- Yes
- Brand name
- GWYN LO
- Reference standard
- Yes
- Dosage form
- SYSTEM
- Route
- TRANSDERMAL
- Marketing status
- Prescription
- Active ingredients
- Name
- ETHINYL ESTRADIOL
- Strength
- 0.02MG/24HR
- Name
- NORELGESTROMIN
- Strength
- 0.22MG/24HR
- Harmonized identifiers (openFDA)
- Application number
- NDA219990
- Brand name
- GWYN LO
- Generic name
- NORELGESTROMIN AND ETHINYL ESTRADIOL
- Manufacturer name
- Viatris Specialty LLC
- Product NDC
- 49502-627
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- TRANSDERMAL
- Substance name
- NORELGESTROMIN, ETHINYL ESTRADIOL
- RxCUI
- 2749430, 2749437
- SPL ID
- e92741f4-87fe-429f-b5b5-c558ed5f4fa9
- SPL set ID
- e92741f4-87fe-429f-b5b5-c558ed5f4fa9
- Package NDC
- 49502-627-61, 49502-627-62, 49502-627-65, 49502-627-63, 49502-627-64
- Nui
- M0447349, N0000175602, N0000175825, N0000000100
- Pharm class cs
- Progesterone Congeners [CS]
- Pharm class epc
- Progestin [EPC], Estrogen [EPC]
- Pharm class moa
- Estrogen Receptor Agonists [MoA]
- UNII
- R0TAY3X631, 423D2T571U