Home Applications 209266 Application 209266
Type ANDA
Sponsor HETERO LABS LTD V Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AVANAFIL AVANAFIL TABLET;ORAL 50MG No No 002 AVANAFIL AVANAFIL TABLET;ORAL 100MG No No 003 AVANAFIL AVANAFIL TABLET;ORAL 200MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209266-001 AVANAFIL AVANAFIL 50MG TABLET / ORAL AB 2024-06-14 A209266-002 AVANAFIL AVANAFIL 100MG TABLET / ORAL AB 2024-06-14 A209266-003 AVANAFIL AVANAFIL 200MG TABLET / ORAL AB 2024-06-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 2 · 45 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 A209266-001 AVANAFIL 50MG TABLET / ORAL AB 2024-06-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209266-002 AVANAFIL 100MG TABLET / ORAL AB 2024-06-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209266-003 AVANAFIL 200MG TABLET / ORAL AB 2024-06-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209266-001 AVANAFIL 50MG TABLET / ORAL AB 2024-06-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209266-002 AVANAFIL 100MG TABLET / ORAL AB 2024-06-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209266-003 AVANAFIL 200MG TABLET / ORAL AB 2024-06-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209266-001 AVANAFIL 50MG TABLET / ORAL AB 2024-06-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209266-002 AVANAFIL 100MG TABLET / ORAL AB 2024-06-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209266-003 AVANAFIL 200MG TABLET / ORAL AB 2024-06-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209266-001 AVANAFIL 50MG TABLET / ORAL AB 2024-06-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209266-002 AVANAFIL 100MG TABLET / ORAL AB 2024-06-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209266-003 AVANAFIL 200MG TABLET / ORAL AB 2024-06-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209266-001 AVANAFIL 50MG TABLET / ORAL AB 2024-06-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209266-002 AVANAFIL 100MG TABLET / ORAL AB 2024-06-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209266-003 AVANAFIL 200MG TABLET / ORAL AB 2024-06-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209266-001 AVANAFIL 50MG TABLET / ORAL AB 2024-06-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209266-002 AVANAFIL 100MG TABLET / ORAL AB 2024-06-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209266-003 AVANAFIL 200MG TABLET / ORAL AB 2024-06-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209266-001 AVANAFIL 50MG TABLET / ORAL AB 2024-06-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209266-002 AVANAFIL 100MG TABLET / ORAL AB 2024-06-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209266-003 AVANAFIL 200MG TABLET / ORAL AB 2024-06-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209266-001 AVANAFIL 50MG TABLET / ORAL AB 2024-06-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209266-002 AVANAFIL 100MG TABLET / ORAL AB 2024-06-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209266-003 AVANAFIL 200MG TABLET / ORAL AB 2024-06-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209266-001 AVANAFIL 50MG TABLET / ORAL AB 2024-06-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209266-002 AVANAFIL 100MG TABLET / ORAL AB 2024-06-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209266-003 AVANAFIL 200MG TABLET / ORAL AB 2024-06-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209266-001 AVANAFIL 50MG TABLET / ORAL AB 2024-06-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209266-002 AVANAFIL 100MG TABLET / ORAL AB 2024-06-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209266-003 AVANAFIL 200MG TABLET / ORAL AB 2024-06-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209266-001 AVANAFIL 50MG TABLET / ORAL AB 2024-06-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209266-002 AVANAFIL 100MG TABLET / ORAL AB 2024-06-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209266-003 AVANAFIL 200MG TABLET / ORAL AB 2024-06-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209266-001 AVANAFIL 50MG TABLET / ORAL AB 2024-06-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209266-002 AVANAFIL 100MG TABLET / ORAL AB 2024-06-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209266-003 AVANAFIL 200MG TABLET / ORAL AB 2024-06-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209266-001 AVANAFIL 50MG TABLET / ORAL AB 2024-06-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209266-002 AVANAFIL 100MG TABLET / ORAL AB 2024-06-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209266-003 AVANAFIL 200MG TABLET / ORAL AB 2024-06-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209266-001 AVANAFIL 50MG TABLET / ORAL AB 2024-06-14 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 45 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 Avanafil AVANAFIL Camber Pharmaceuticals, Inc. 1d04e17d-7399-430a-a8bb-fa1912b155e9 2025-12-17 Warnings, Adverse reactions Exact identifier application applno (ANDA): 209266 application number: ANDA209266