Application 019190

Type
NDA
Sponsor
WYETH PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRIPHASIL-28ETHINYL ESTRADIOL; LEVONORGESTRELTABLET;ORAL-280.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019190-001TRIPHASIL-28ETHINYL ESTRADIOL; LEVONORGESTREL0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD1984-11-01

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N019190-001TRIPHASIL-280.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD1984-11-01f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019190-001TRIPHASIL-280.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD1984-11-01e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N019190-001TRIPHASIL-280.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD1984-11-01cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N019190-001TRIPHASIL-280.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD1984-11-01a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70924SUPPL2022-05-03
70891SUPPL2022-05-02
58683SUPPL2019-05-14
58650SUPPL2019-05-13
49400SUPPL2017-08-15
49309SUPPL2017-08-10
11447SUPPL2016-04-07