Home Applications 022332 Application 022332
Type NDA
Sponsor ELI LILLY CO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ADCIRCA TADALAFIL TABLET;ORAL 20MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N022332-001 ADCIRCA TADALAFIL 20MG TABLET / ORAL AB2 RLD, RS 2009-05-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022332-001 AB2
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 2 · 42 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 2026-08-18 06:07:40 2026-07 N022332-001 ADCIRCA 20MG TABLET / ORAL AB2 RLD, RS 2009-05-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022332-001 ADCIRCA 20MG TABLET / ORAL AB2 RLD, RS 2009-05-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022332-001 ADCIRCA 20MG TABLET / ORAL AB2 RLD, RS 2009-05-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022332-001 ADCIRCA 20MG TABLET / ORAL AB2 RLD, RS 2009-05-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022332-001 ADCIRCA 20MG TABLET / ORAL AB2 RLD, RS 2009-05-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022332-001 ADCIRCA 20MG TABLET / ORAL AB2 RLD, RS 2009-05-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022332-001 ADCIRCA 20MG TABLET / ORAL AB2 RLD, RS 2009-05-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022332-001 ADCIRCA 20MG TABLET / ORAL AB2 RLD, RS 2009-05-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022332-001 ADCIRCA 20MG TABLET / ORAL AB2 RLD, RS 2009-05-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022332-001 ADCIRCA 20MG TABLET / ORAL AB2 RLD, RS 2009-05-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022332-001 ADCIRCA 20MG TABLET / ORAL AB2 RLD, RS 2009-05-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022332-001 ADCIRCA 20MG TABLET / ORAL AB2 RLD, RS 2009-05-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022332-001 ADCIRCA 20MG TABLET / ORAL AB2 RLD, RS 2009-05-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022332-001 ADCIRCA 20MG TABLET / ORAL AB2 RLD, RS 2009-05-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022332-001 ADCIRCA 20MG TABLET / ORAL AB2 RLD, RS 2009-05-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022332-001 ADCIRCA 20MG TABLET / ORAL AB2 RLD, RS 2009-05-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022332-001 ADCIRCA 20MG TABLET / ORAL AB2 RLD, RS 2009-05-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022332-001 ADCIRCA 20MG TABLET / ORAL AB2 RLD, RS 2009-05-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022332-001 ADCIRCA 20MG TABLET / ORAL AB2 RLD, RS 2009-05-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022332-001 ADCIRCA 20MG TABLET / ORAL AB2 RLD, RS 2009-05-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022332-001 ADCIRCA 20MG TABLET / ORAL AB2 RLD, RS 2009-05-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022332-001 ADCIRCA 20MG TABLET / ORAL AB2 RLD, RS 2009-05-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022332-001 ADCIRCA 20MG TABLET / ORAL AB2 RLD, RS 2009-05-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022332-001 ADCIRCA 20MG TABLET / ORAL AB2 RLD, RS 2009-05-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022332-001 ADCIRCA 20MG TABLET / ORAL AB2 RLD, RS 2009-05-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022332-001 ADCIRCA 20MG TABLET / ORAL AB2 RLD, RS 2009-05-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022332-001 ADCIRCA 20MG TABLET / ORAL AB2 RLD, RS 2009-05-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022332-001 ADCIRCA 20MG TABLET / ORAL AB2 RLD, RS 2009-05-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022332-001 ADCIRCA 20MG TABLET / ORAL AB2 RLD, RS 2009-05-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022332-001 ADCIRCA 20MG TABLET / ORAL AB2 RLD, RS 2009-05-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022332-001 ADCIRCA 20MG TABLET / ORAL AB2 RLD, RS 2009-05-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022332-001 ADCIRCA 20MG TABLET / ORAL AB2 RLD, RS 2009-05-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022332-001 ADCIRCA 20MG TABLET / ORAL AB2 RLD, RS 2009-05-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022332-001 ADCIRCA 20MG TABLET / ORAL AB2 RLD, RS 2009-05-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022332-001 ADCIRCA 20MG TABLET / ORAL AB2 RLD, RS 2009-05-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022332-001 ADCIRCA 20MG TABLET / ORAL AB2 RLD, RS 2009-05-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022332-001 ADCIRCA 20MG TABLET / ORAL AB2 RLD, RS 2009-05-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022332-001 ADCIRCA 20MG TABLET / ORAL AB2 RLD, RS 2009-05-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022332-001 ADCIRCA 20MG TABLET / ORAL AB2 RLD, RS 2009-05-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022332-001 ADCIRCA 20MG TABLET / ORAL AB2 RLD, RS 2009-05-22 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 43353-070 ADCIRCA Tadalafil Aphena Pharma Solutions - Tennessee, LLC NDA Current 43353-070 ADCIRCA Tadalafil Aphena Pharma Solutions - Tennessee, LLC NDA Current 66302-467 ADCIRCA Tadalafil United Therapeutics Corporation NDA Current 66302-467 ADCIRCA Tadalafil United Therapeutics Corporation NDA Current 66302-467 ADCIRCA Tadalafil United Therapeutics Corporation NDA Current 66302-467 ADCIRCA Tadalafil United Therapeutics Corporation NDA Current 66302-467 ADCIRCA Tadalafil United Therapeutics Corporation NDA Current 66302-467 ADCIRCA Tadalafil United Therapeutics Corporation NDA Current