Home Applications 218031 Application 218031
Type ANDA
Sponsor NOVAST LABS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DROSPIRENONE AND ESTRADIOL DROSPIRENONE; ESTRADIOL TABLET;ORAL 0.5MG;1MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A218031-001 DROSPIRENONE AND ESTRADIOL DROSPIRENONE; ESTRADIOL 0.5MG;1MG TABLET / ORAL AB 2025-10-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218031-001 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 2026-09-14 22:38:34 2026-08 A218031-001 DROSPIRENONE AND ESTRADIOL 0.5MG;1MG TABLET / ORAL AB 2025-10-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218031-001 DROSPIRENONE AND ESTRADIOL 0.5MG;1MG TABLET / ORAL AB 2025-10-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218031-001 DROSPIRENONE AND ESTRADIOL 0.5MG;1MG TABLET / ORAL AB 2025-10-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218031-001 DROSPIRENONE AND ESTRADIOL 0.5MG;1MG TABLET / ORAL AB 2025-10-28 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218031-001 DROSPIRENONE AND ESTRADIOL 0.5MG;1MG TABLET / ORAL AB 2025-10-28 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 84013 ORIG 2025-10-31