Home Applications 201886 Application 201886
Type ANDA
Sponsor LUPIN LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VYFEMLA ETHINYL ESTRADIOL; NORETHINDRONE TABLET;ORAL-28 0.035MG;0.4MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A201886-001 VYFEMLA ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.4MG TABLET / ORAL-28 AB 2013-09-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A201886-001 AB
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.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A201886-001 VYFEMLA 0.035MG;0.4MG TABLET / ORAL-28 AB 2013-09-26 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A201886-001 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Vyfemla NORETHINDRONE AND ETHINYL ESTRADIOL Lupin Pharmaceuticals, Inc. 175ce5c4-d332-4c97-a0b8-10821dc813ef 2025-11-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 201886 application number: ANDA201886 ndc (product): 68180-875
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 57297-875 Vyfemla norethindrone and ethinyl estradiol LUPIN LIMITED ANDA Current 68180-875 Vyfemla norethindrone and ethinyl estradiol Lupin Pharmaceuticals, Inc. ANDA Current 68180-875 Vyfemla norethindrone and ethinyl estradiol Lupin Pharmaceuticals, Inc. ANDA Current 68180-875 Vyfemla norethindrone and ethinyl estradiol Lupin Pharmaceuticals, Inc. ANDA Current 68180-875 Vyfemla norethindrone and ethinyl estradiol Lupin Pharmaceuticals, Inc. ANDA Current