Home Applications 202276 Application 202276
Type NDA
Sponsor METUCHEN PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 STENDRA AVANAFIL TABLET;ORAL 50MG Yes No 002 STENDRA AVANAFIL TABLET;ORAL 100MG Yes No 003 STENDRA AVANAFIL TABLET;ORAL 200MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 N202276-001 STENDRA AVANAFIL 50MG TABLET / ORAL AB RLD 2012-04-27 N202276-002 STENDRA AVANAFIL 100MG TABLET / ORAL AB RLD 2012-04-27 N202276-003 STENDRA AVANAFIL 200MG TABLET / ORAL AB RLD, RS 2012-04-27
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 4 · 132 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 2026-10-15 13:18:30 2026-09 N202276-001 STENDRA 50MG TABLET / ORAL AB RLD 2012-04-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 N202276-002 STENDRA 100MG TABLET / ORAL AB RLD 2012-04-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 N202276-003 STENDRA 200MG TABLET / ORAL AB RLD, RS 2012-04-27 c2088c7a36db…2026-09-14 22:38:34 2026-08 N202276-001 STENDRA 50MG TABLET / ORAL AB RLD 2012-04-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202276-002 STENDRA 100MG TABLET / ORAL AB RLD 2012-04-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202276-003 STENDRA 200MG TABLET / ORAL AB RLD, RS 2012-04-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 N202276-001 STENDRA 50MG TABLET / ORAL AB RLD 2012-04-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202276-002 STENDRA 100MG TABLET / ORAL AB RLD 2012-04-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202276-003 STENDRA 200MG TABLET / ORAL AB RLD, RS 2012-04-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N202276-001 STENDRA 50MG TABLET / ORAL AB RLD 2012-04-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202276-002 STENDRA 100MG TABLET / ORAL AB RLD 2012-04-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202276-003 STENDRA 200MG TABLET / ORAL AB RLD, RS 2012-04-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202276-001 STENDRA 50MG TABLET / ORAL AB RLD 2012-04-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202276-002 STENDRA 100MG TABLET / ORAL AB RLD 2012-04-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202276-003 STENDRA 200MG TABLET / ORAL AB RLD, RS 2012-04-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202276-001 STENDRA 50MG TABLET / ORAL AB RLD 2012-04-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202276-002 STENDRA 100MG TABLET / ORAL AB RLD 2012-04-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202276-003 STENDRA 200MG TABLET / ORAL AB RLD, RS 2012-04-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202276-001 STENDRA 50MG TABLET / ORAL AB RLD 2012-04-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202276-002 STENDRA 100MG TABLET / ORAL AB RLD 2012-04-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202276-003 STENDRA 200MG TABLET / ORAL AB RLD, RS 2012-04-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202276-001 STENDRA 50MG TABLET / ORAL AB RLD 2012-04-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202276-002 STENDRA 100MG TABLET / ORAL AB RLD 2012-04-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202276-003 STENDRA 200MG TABLET / ORAL AB RLD, RS 2012-04-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202276-001 STENDRA 50MG TABLET / ORAL AB RLD 2012-04-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202276-002 STENDRA 100MG TABLET / ORAL AB RLD 2012-04-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202276-003 STENDRA 200MG TABLET / ORAL AB RLD, RS 2012-04-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202276-001 STENDRA 50MG TABLET / ORAL AB RLD 2012-04-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202276-002 STENDRA 100MG TABLET / ORAL AB RLD 2012-04-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202276-003 STENDRA 200MG TABLET / ORAL AB RLD, RS 2012-04-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202276-001 STENDRA 50MG TABLET / ORAL AB RLD 2012-04-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202276-002 STENDRA 100MG TABLET / ORAL AB RLD 2012-04-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202276-003 STENDRA 200MG TABLET / ORAL AB RLD, RS 2012-04-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202276-001 STENDRA 50MG TABLET / ORAL AB RLD 2012-04-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202276-002 STENDRA 100MG TABLET / ORAL AB RLD 2012-04-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202276-003 STENDRA 200MG TABLET / ORAL AB RLD, RS 2012-04-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202276-001 STENDRA 50MG TABLET / ORAL AB RLD 2012-04-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N202276-002 STENDRA 100MG TABLET / ORAL AB RLD 2012-04-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N202276-003 STENDRA 200MG TABLET / ORAL AB RLD, RS 2012-04-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202276-001 STENDRA 50MG TABLET / ORAL AB RLD 2012-04-27 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 48 observed states.
Observed Orange Book patent history# Patent history page 2 of 5 · 189 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202276-001 6656935 2025-04-27 U-155 Drug substance, Drug product 2012-05-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202276-002 7501409 2023-05-05 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202276-002 6656935 2025-04-27 U-155 Drug substance, Drug product 2012-05-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202276-003 7501409 2023-05-05 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202276-003 6656935 2025-04-27 U-155 Drug substance, Drug product 2012-05-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N202276-001 7501409 2023-05-05 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N202276-001 6656935 2025-04-27 U-155 Drug substance, Drug product 2012-05-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N202276-002 7501409 2023-05-05 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N202276-002 6656935 2025-04-27 U-155 Drug substance, Drug product 2012-05-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N202276-003 7501409 2023-05-05 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N202276-003 6656935 2025-04-27 U-155 Drug substance, Drug product 2012-05-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N202276-001 7501409 2023-05-05 Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N202276-001 6656935 2025-04-27 U-155 Drug substance, Drug product 2012-05-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N202276-002 7501409 2023-05-05 Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N202276-002 6656935 2025-04-27 U-155 Drug substance, Drug product 2012-05-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N202276-003 7501409 2023-05-05 Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N202276-003 6656935 2025-04-27 U-155 Drug substance, Drug product 2012-05-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N202276-001 7501409 2023-05-05 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N202276-001 6656935 2025-04-27 U-155 Drug substance, Drug product 2012-05-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N202276-002 7501409 2023-05-05 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N202276-002 6656935 2025-04-27 U-155 Drug substance, Drug product 2012-05-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N202276-003 7501409 2023-05-05 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N202276-003 6656935 2025-04-27 U-155 Drug substance, Drug product 2012-05-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N202276-001 7501409 2023-05-05 Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N202276-001 6656935 2025-04-27 U-155 Drug substance, Drug product 2012-05-29 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N202276-002 7501409 2023-05-05 Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N202276-002 6656935 2025-04-27 U-155 Drug substance, Drug product 2012-05-29 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N202276-003 7501409 2023-05-05 Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N202276-003 6656935 2025-04-27 U-155 Drug substance, Drug product 2012-05-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N202276-001 7501409 2023-05-05 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N202276-001 6656935 2025-04-27 U-155 Drug substance, Drug product 2012-05-29 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N202276-002 7501409 2023-05-05 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N202276-002 6656935 2025-04-27 U-155 Drug substance, Drug product 2012-05-29 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N202276-003 7501409 2023-05-05 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N202276-003 6656935 2025-04-27 U-155 Drug substance, Drug product 2012-05-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202276-001 7501409 2023-05-05 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202276-001 6656935 2025-04-27 U-155 Drug substance, Drug product 2012-05-29 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202276-002 7501409 2023-05-05 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202276-002 6656935 2025-04-27 U-155 Drug substance, Drug product 2012-05-29 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202276-003 7501409 2023-05-05 Drug product 87673890dc5c…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 66 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 Name fallback generic name: AVANAFIL
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 · 27 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 62541-501 STENDRA Avanafil Vivus LLC NDA Current 62541-501 STENDRA Avanafil Vivus LLC NDA Current 62541-502 STENDRA Avanafil Vivus LLC NDA Current 62541-502 STENDRA Avanafil Vivus LLC NDA Current 62541-503 STENDRA Avanafil Vivus LLC NDA Current 62541-503 STENDRA Avanafil Vivus LLC NDA Current 72384-751 Stendra avanafil Metuchen Pharmaceuticals, LLC NDA Current 72384-751 Stendra avanafil Metuchen Pharmaceuticals, LLC NDA Current 72384-751 Stendra avanafil Metuchen Pharmaceuticals, LLC NDA Current 72384-751 Stendra avanafil Metuchen Pharmaceuticals, LLC NDA Current 72384-752 Stendra avanafil Metuchen Pharmaceuticals, LLC NDA Current 72384-752 Stendra avanafil Metuchen Pharmaceuticals, LLC NDA Current 72384-752 Stendra avanafil Metuchen Pharmaceuticals, LLC NDA Current 72384-752 Stendra avanafil Metuchen Pharmaceuticals, LLC NDA Current 72384-753 Stendra avanafil Metuchen Pharmaceuticals, LLC NDA Current 72384-753 Stendra avanafil Metuchen Pharmaceuticals, LLC NDA Current 72384-753 Stendra avanafil Metuchen Pharmaceuticals, LLC NDA Current 72384-753 Stendra avanafil Metuchen Pharmaceuticals, LLC NDA Current 76299-320 Stendra avanafil Mist Pharmaceuticals, LLC NDA Current 76299-320 Stendra avanafil Mist Pharmaceuticals, LLC NDA Current 76299-320 Stendra avanafil Metuchen Pharmaceuticals, LLC NDA Current 76299-321 Stendra avanafil Mist Pharmaceuticals, LLC NDA Current 76299-321 Stendra avanafil Mist Pharmaceuticals, LLC NDA Current 76299-321 Stendra avanafil Metuchen Pharmaceuticals, LLC NDA Current 76299-322 Stendra avanafil Mist Pharmaceuticals, LLC NDA Current 76299-322 Stendra avanafil Mist Pharmaceuticals, LLC NDA Current 76299-322 Stendra avanafil Metuchen Pharmaceuticals, LLC NDA Current