Home Applications 021367 Application 021367
Type NDA
Sponsor MILLICENT Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FEMRING ESTRADIOL ACETATE INSERT, EXTENDED RELEASE;VAGINAL EQ 0.05MG BASE/24HR Yes No 002 FEMRING ESTRADIOL ACETATE INSERT, EXTENDED RELEASE;VAGINAL EQ 0.1MG BASE/24HR Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021367-001 FEMRING ESTRADIOL ACETATE EQ 0.05MG BASE/24HR INSERT, EXTENDED RELEASE / VAGINAL RLD 2003-03-20 N021367-002 FEMRING ESTRADIOL ACETATE EQ 0.1MG BASE/24HR INSERT, EXTENDED RELEASE / VAGINAL RLD, RS 2003-03-20
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 3 of 3 · 88 observed 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 2022-10-28 04:53 UTC 2022-10 N021367-001 FEMRING EQ 0.05MG BASE/24HR INSERT, EXTENDED RELEASE / VAGINAL RLD 2003-03-20 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N021367-002 FEMRING EQ 0.1MG BASE/24HR INSERT, EXTENDED RELEASE / VAGINAL RLD, RS 2003-03-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021367-001 FEMRING EQ 0.05MG BASE/24HR INSERT, EXTENDED RELEASE / VAGINAL RLD 2003-03-20 e64feba35796…2022-09-29 23:25 UTC 2022-09 N021367-002 FEMRING EQ 0.1MG BASE/24HR INSERT, EXTENDED RELEASE / VAGINAL RLD, RS 2003-03-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021367-001 FEMRING EQ 0.05MG BASE/24HR INSERT, EXTENDED RELEASE / VAGINAL RLD 2003-03-20 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021367-002 FEMRING EQ 0.1MG BASE/24HR INSERT, EXTENDED RELEASE / VAGINAL RLD, RS 2003-03-20 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021367-001 FEMRING EQ 0.05MG BASE/24HR INSERT, EXTENDED RELEASE / VAGINAL RLD 2003-03-20 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021367-002 FEMRING EQ 0.1MG BASE/24HR INSERT, EXTENDED RELEASE / VAGINAL RLD, RS 2003-03-20 a50c72e98297…
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0023-5868 Femring estradiol acetate Allergan, Inc. NDA Current 0023-5869 Femring estradiol acetate Allergan, Inc. NDA Current 72495-201 Femring estradiol acetate Millicent US, Inc. NDA Current 72495-201 Femring estradiol acetate Millicent US, Inc. NDA Current 72495-201 Femring estradiol acetate Millicent US, Inc. NDA Current 72495-201 Femring estradiol acetate Millicent US, Inc. NDA Current 72495-202 Femring estradiol acetate Millicent US, Inc. NDA Current 72495-202 Femring estradiol acetate Millicent US, Inc. NDA Current 72495-202 Femring estradiol acetate Millicent US, Inc. NDA Current 72495-202 Femring estradiol acetate Millicent US, Inc. NDA Current