Home Applications 020538 Application 020538
Type NDA
Sponsor NOVARTIS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ESTRADIOL ESTRADIOL Film, Extended Release; Transdermal 0.0375MG/24HR No No 002 ESTRADIOL ESTRADIOL Film, Extended Release; Transdermal 0.075MG/24HR No No 003 ESTRADIOL ESTRADIOL Film, Extended Release; Transdermal 0.05MG/24HR No No 004 ESTRADIOL ESTRADIOL Film, Extended Release; Transdermal 0.1MG/24HR No No 005 VIVELLE-DOT ESTRADIOL FILM, EXTENDED RELEASE;TRANSDERMAL 0.0375MG/24HR Yes No 006 VIVELLE-DOT ESTRADIOL FILM, EXTENDED RELEASE;TRANSDERMAL 0.05MG/24HR Yes No 007 VIVELLE-DOT ESTRADIOL FILM, EXTENDED RELEASE;TRANSDERMAL 0.075MG/24HR Yes No 008 VIVELLE-DOT ESTRADIOL FILM, EXTENDED RELEASE;TRANSDERMAL 0.1MG/24HR Yes Yes 009 VIVELLE-DOT ESTRADIOL FILM, EXTENDED RELEASE;TRANSDERMAL 0.025MG/24HR Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020538-005 VIVELLE-DOT ESTRADIOL 0.0375MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 N020538-006 VIVELLE-DOT ESTRADIOL 0.05MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 N020538-007 VIVELLE-DOT ESTRADIOL 0.075MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 N020538-008 VIVELLE-DOT ESTRADIOL 0.1MG/24HR SYSTEM / TRANSDERMAL AB1 RLD, RS 1999-01-08 N020538-009 VIVELLE-DOT ESTRADIOL 0.025MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 2002-05-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 matching rows.
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 1 of 6 · 215 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 2026-09-14 22:38:34 2026-08 N020538-005 VIVELLE-DOT 0.0375MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020538-006 VIVELLE-DOT 0.05MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020538-007 VIVELLE-DOT 0.075MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020538-008 VIVELLE-DOT 0.1MG/24HR SYSTEM / TRANSDERMAL AB1 RLD, RS 1999-01-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020538-009 VIVELLE-DOT 0.025MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 2002-05-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020538-005 VIVELLE-DOT 0.0375MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020538-006 VIVELLE-DOT 0.05MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020538-007 VIVELLE-DOT 0.075MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020538-008 VIVELLE-DOT 0.1MG/24HR SYSTEM / TRANSDERMAL AB1 RLD, RS 1999-01-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020538-009 VIVELLE-DOT 0.025MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 2002-05-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020538-005 VIVELLE-DOT 0.0375MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020538-006 VIVELLE-DOT 0.05MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020538-007 VIVELLE-DOT 0.075MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020538-008 VIVELLE-DOT 0.1MG/24HR SYSTEM / TRANSDERMAL AB1 RLD, RS 1999-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020538-009 VIVELLE-DOT 0.025MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 2002-05-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020538-005 VIVELLE-DOT 0.0375MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020538-006 VIVELLE-DOT 0.05MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020538-007 VIVELLE-DOT 0.075MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020538-008 VIVELLE-DOT 0.1MG/24HR SYSTEM / TRANSDERMAL AB1 RLD, RS 1999-01-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020538-009 VIVELLE-DOT 0.025MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 2002-05-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020538-005 VIVELLE-DOT 0.0375MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020538-006 VIVELLE-DOT 0.05MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020538-007 VIVELLE-DOT 0.075MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020538-008 VIVELLE-DOT 0.1MG/24HR SYSTEM / TRANSDERMAL AB1 RLD, RS 1999-01-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020538-009 VIVELLE-DOT 0.025MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 2002-05-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020538-005 VIVELLE-DOT 0.0375MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020538-006 VIVELLE-DOT 0.05MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020538-007 VIVELLE-DOT 0.075MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020538-008 VIVELLE-DOT 0.1MG/24HR SYSTEM / TRANSDERMAL AB1 RLD, RS 1999-01-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020538-009 VIVELLE-DOT 0.025MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 2002-05-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020538-005 VIVELLE-DOT 0.0375MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020538-006 VIVELLE-DOT 0.05MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020538-007 VIVELLE-DOT 0.075MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020538-008 VIVELLE-DOT 0.1MG/24HR SYSTEM / TRANSDERMAL AB1 RLD, RS 1999-01-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020538-009 VIVELLE-DOT 0.025MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 2002-05-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020538-005 VIVELLE-DOT 0.0375MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020538-006 VIVELLE-DOT 0.05MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020538-007 VIVELLE-DOT 0.075MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 1999-01-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020538-008 VIVELLE-DOT 0.1MG/24HR SYSTEM / TRANSDERMAL AB1 RLD, RS 1999-01-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020538-009 VIVELLE-DOT 0.025MG/24HR SYSTEM / TRANSDERMAL AB1 RLD 2002-05-03 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 3 of 6 · 215 observed states.
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 · 52 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0078-0343 Vivelle-Dot estradiol Novartis Pharmaceuticals Corporation NDA Current 0078-0343 Vivelle-Dot estradiol Novartis Pharmaceuticals Corporation NDA Current 0078-0343 Vivelle-Dot estradiol Novartis Pharmaceuticals Corporation NDA Current 0078-0343 Vivelle-Dot estradiol Novartis Pharmaceuticals Corporation NDA Current 0078-0343 Vivelle-Dot estradiol Novartis Pharmaceuticals Corporation NDA Current 0078-0344 Vivelle-Dot estradiol Novartis Pharmaceuticals Corporation NDA Current 0078-0344 Vivelle-Dot estradiol Novartis Pharmaceuticals Corporation NDA Current 0078-0344 Vivelle-Dot estradiol Novartis Pharmaceuticals Corporation NDA Current 0078-0344 Vivelle-Dot estradiol Novartis Pharmaceuticals Corporation NDA Current 0078-0344 Vivelle-Dot estradiol Novartis Pharmaceuticals Corporation NDA Current 0078-0345 Vivelle-Dot estradiol Novartis Pharmaceuticals Corporation NDA Current 0078-0345 Vivelle-Dot estradiol Novartis Pharmaceuticals Corporation NDA Current 0078-0345 Vivelle-Dot estradiol Novartis Pharmaceuticals Corporation NDA Current 0078-0345 Vivelle-Dot estradiol Novartis Pharmaceuticals Corporation NDA Current 0078-0345 Vivelle-Dot estradiol Novartis Pharmaceuticals Corporation NDA Current 0078-0346 Vivelle-Dot estradiol Novartis Pharmaceuticals Corporation NDA Current 0078-0346 Vivelle-Dot estradiol Novartis Pharmaceuticals Corporation NDA Current 0078-0346 Vivelle-Dot estradiol Novartis Pharmaceuticals Corporation NDA Current 0078-0346 Vivelle-Dot estradiol Novartis Pharmaceuticals Corporation NDA Current 0078-0346 Vivelle-Dot estradiol Novartis Pharmaceuticals Corporation NDA Current 0078-0365 Vivelle-Dot estradiol Novartis Pharmaceuticals Corporation NDA Current 0078-0365 Vivelle-Dot estradiol Novartis Pharmaceuticals Corporation NDA Current 0078-0365 Vivelle-Dot estradiol Novartis Pharmaceuticals Corporation NDA Current 0078-0365 Vivelle-Dot estradiol Novartis Pharmaceuticals Corporation NDA Current 0078-0365 Vivelle-Dot estradiol Novartis Pharmaceuticals Corporation NDA Current 0781-7129 Estradiol estradiol Sandoz Inc NDA AUTHORIZED GENERIC Current 0781-7129 Estradiol estradiol Sandoz Inc NDA AUTHORIZED GENERIC Current 0781-7129 Estradiol estradiol Sandoz Inc NDA AUTHORIZED GENERIC Current 0781-7129 Estradiol estradiol Sandoz Inc NDA AUTHORIZED GENERIC Current 0781-7129 Estradiol estradiol Sandoz Inc NDA AUTHORIZED GENERIC Current 0781-7138 Estradiol estradiol Sandoz Inc NDA AUTHORIZED GENERIC Current 0781-7138 Estradiol estradiol Sandoz Inc NDA AUTHORIZED GENERIC Current 0781-7138 Estradiol estradiol Sandoz Inc NDA AUTHORIZED GENERIC Current 0781-7138 Estradiol estradiol Sandoz Inc NDA AUTHORIZED GENERIC Current 0781-7138 Estradiol estradiol Sandoz Inc NDA AUTHORIZED GENERIC Current 0781-7144 Estradiol estradiol Sandoz Inc NDA AUTHORIZED GENERIC Current 0781-7144 Estradiol estradiol Sandoz Inc NDA AUTHORIZED GENERIC Current 0781-7144 Estradiol estradiol Sandoz Inc NDA AUTHORIZED GENERIC Current 0781-7144 Estradiol estradiol Sandoz Inc NDA AUTHORIZED GENERIC Current 0781-7144 Estradiol estradiol Sandoz Inc NDA AUTHORIZED GENERIC Current 0781-7156 Estradiol estradiol Sandoz Inc NDA AUTHORIZED GENERIC Current 0781-7156 Estradiol estradiol Sandoz Inc NDA AUTHORIZED GENERIC Current 0781-7156 Estradiol estradiol Sandoz Inc NDA AUTHORIZED GENERIC Current 0781-7156 Estradiol estradiol Sandoz Inc NDA AUTHORIZED GENERIC Current 0781-7156 Estradiol estradiol Sandoz Inc NDA AUTHORIZED GENERIC Current 0781-7167 Estradiol estradiol Sandoz Inc NDA AUTHORIZED GENERIC Current 0781-7167 Estradiol estradiol Sandoz Inc NDA AUTHORIZED GENERIC Current 0781-7167 Estradiol estradiol Sandoz Inc NDA AUTHORIZED GENERIC Current 0781-7167 Estradiol estradiol Sandoz Inc NDA AUTHORIZED GENERIC Current 0781-7167 Estradiol estradiol Sandoz Inc NDA AUTHORIZED GENERIC Current 68071-3326 Estradiol estradiol NuCare Pharmaceuticals,Inc. NDA AUTHORIZED GENERIC Current 68071-3326 Estradiol estradiol NuCare Pharmaceuticals,Inc. NDA AUTHORIZED GENERIC Current