Home Applications 209654 Application 209654
Type ANDA
Sponsor AJANTA PHARMA LTD 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 43 .
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 A209654-001 TADALAFIL TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 A209654-002 TADALAFIL TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 A209654-003 TADALAFIL TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 A209654-004 TADALAFIL TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26
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 · 172 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 A209654-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209654-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209654-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209654-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209654-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209654-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209654-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209654-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209654-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209654-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209654-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209654-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209654-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209654-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209654-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209654-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209654-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209654-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209654-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209654-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209654-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209654-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209654-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209654-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209654-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209654-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209654-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209654-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209654-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209654-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209654-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209654-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209654-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209654-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209654-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209654-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209654-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209654-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209654-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209654-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 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 2 of 2 · 21 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 · 59 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 27241-111 Tadalafil Tadalafil Ajanta Pharma USA Inc. ANDA Current 27241-111 Tadalafil Tadalafil Ajanta Pharma Limited ANDA Current 27241-111 Tadalafil Tadalafil Ajanta Pharma Limited ANDA Current 27241-111 Tadalafil Tadalafil Ajanta Pharma USA Inc. ANDA Current 27241-111 Tadalafil Tadalafil Ajanta Pharma Limited ANDA Current 27241-111 Tadalafil Tadalafil Ajanta Pharma Limited ANDA Current 27241-112 Tadalafil Tadalafil Ajanta Pharma USA Inc. ANDA Current 27241-112 Tadalafil Tadalafil Ajanta Pharma Limited ANDA Current 27241-112 Tadalafil Tadalafil Ajanta Pharma Limited ANDA Current 27241-112 Tadalafil Tadalafil Ajanta Pharma USA Inc. ANDA Current 27241-112 Tadalafil Tadalafil Ajanta Pharma Limited ANDA Current 27241-112 Tadalafil Tadalafil Ajanta Pharma Limited ANDA Current 27241-113 Tadalafil Tadalafil Ajanta Pharma USA Inc. ANDA Current 27241-113 Tadalafil Tadalafil Ajanta Pharma Limited ANDA Current 27241-113 Tadalafil Tadalafil Ajanta Pharma Limited ANDA Current 27241-113 Tadalafil Tadalafil Ajanta Pharma USA Inc. ANDA Current 27241-113 Tadalafil Tadalafil Ajanta Pharma Limited ANDA Current 27241-113 Tadalafil Tadalafil Ajanta Pharma Limited ANDA Current 27241-114 Tadalafil Tadalafil Ajanta Pharma USA Inc. ANDA Current 27241-114 Tadalafil Tadalafil Ajanta Pharma Limited ANDA Current 27241-114 Tadalafil Tadalafil Ajanta Pharma Limited ANDA Current 27241-114 Tadalafil Tadalafil Ajanta Pharma USA Inc. ANDA Current 27241-114 Tadalafil Tadalafil Ajanta Pharma Limited ANDA Current 27241-114 Tadalafil Tadalafil Ajanta Pharma Limited ANDA Current 50090-5344 Tadalafil Tadalafil A-S Medication Solutions ANDA Current 50090-5641 Tadalafil Tadalafil A-S Medication Solutions ANDA Current 50436-0114 Tadalafil Tadalafil Unit Dose Services ANDA Current 50436-1120 Tadalafil Tadalafil Unit Dose Services ANDA Current 50436-1120 Tadalafil Tadalafil Unit Dose Services ANDA Current 63629-8288 Tadalafil Tadalafil Bryant Ranch Prepack ANDA Current 63629-8288 Tadalafil Tadalafil Bryant Ranch Prepack ANDA Current 68071-2417 Tadalafil Tadalafil NUCARE PHARMACEUTICALS INC ANDA Current 68071-2417 Tadalafil Tadalafil NUCARE PHARMACEUTICALS INC ANDA Current 68071-2421 Tadalafil Tadalafil NuCare Pharmaceuticals,Inc. ANDA Current 68071-2421 Tadalafil Tadalafil NuCare Pharmaceuticals,Inc. ANDA Current 68071-2421 Tadalafil Tadalafil NuCare Pharmaceuticals,Inc. ANDA Current 68071-2421 Tadalafil Tadalafil NuCare Pharmaceuticals,Inc. ANDA Current 68071-2451 Tadalafil Tadalafil NuCare Pharmaceuticals,Inc. ANDA Current 68071-2554 Tadalafil Tadalafil NuCare Pharmaceuticals,Inc. ANDA Current 68071-2613 Tadalafil Tadalafil NuCare Pharmaceuticals,Inc. ANDA Current 68071-2632 Tadalafil Tadalafil NuCare Pharmaceuticals,Inc. ANDA Current 68788-8292 Tadalafil Tadalafil Preferred Pharmaceuticals Inc. ANDA Current 70518-3434 Tadalafil Tadalafil REMEDYREPACK INC. ANDA Current 70518-3434 Tadalafil Tadalafil REMEDYREPACK INC. ANDA Current 70518-3434 Tadalafil Tadalafil REMEDYREPACK INC. ANDA Current 71205-734 Tadalafil Tadalafil Proficient Rx LP ANDA Current 71205-735 Tadalafil Tadalafil Proficient Rx LP ANDA Current 71205-736 Tadalafil Tadalafil Proficient Rx LP ANDA Current 71335-1491 Tadalafil Tadalafil Bryant Ranch Prepack ANDA Current 71335-1491 Tadalafil Tadalafil Bryant Ranch Prepack ANDA Current 71335-1491 Tadalafil Tadalafil Bryant Ranch Prepack ANDA Current 71335-1670 Tadalafil Tadalafil Bryant Ranch Prepack ANDA Current 71335-1670 Tadalafil Tadalafil Bryant Ranch Prepack ANDA Current 71335-1670 Tadalafil Tadalafil Bryant Ranch Prepack ANDA Current 71335-1823 Tadalafil Tadalafil Bryant Ranch Prepack ANDA Current 71610-461 Tadalafil Tadalafil Aphena Pharma Solutions - Tennessee, LLC ANDA Current 72189-145 TADALAFIL TADALAFIL direct rx ANDA Current 72789-184 Tadalafil Tadalafil PD-Rx Pharmaceuticals, Inc. ANDA Current 72789-184 Tadalafil Tadalafil PD-Rx Pharmaceuticals, Inc. ANDA Current