Home Applications 205885 Application 205885
Type ANDA
Sponsor WATSON LABS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TADALAFIL TADALAFIL TABLET;ORAL 2.5MG No No 002 TADALAFIL TADALAFIL TABLET;ORAL 5MG No No 003 TADALAFIL TADALAFIL TABLET;ORAL 10MG No No 004 TADALAFIL TADALAFIL TABLET;ORAL 20MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A205885-001 TADALAFIL TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-29 A205885-002 TADALAFIL TADALAFIL 5MG TABLET / ORAL AB1 2019-03-29 A205885-003 TADALAFIL TADALAFIL 10MG TABLET / ORAL AB1 2019-03-29 A205885-004 TADALAFIL TADALAFIL 20MG TABLET / ORAL AB1 2019-03-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 5 · 168 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 A205885-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205885-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205885-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205885-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205885-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205885-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205885-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205885-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205885-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205885-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205885-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205885-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205885-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205885-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205885-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205885-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205885-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205885-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205885-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205885-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205885-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205885-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205885-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205885-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205885-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205885-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205885-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205885-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205885-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205885-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205885-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205885-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205885-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205885-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205885-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205885-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205885-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205885-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205885-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205885-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-29 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tadalafil TADALAFIL Teva Pharmaceuticals, Inc. 3ad14d63-42e7-493f-b56c-e02a4fd139f7 2025-03-01 Warnings, Adverse reactions Exact identifier application applno (ANDA): 205885 application number: ANDA205885