Home Applications 213032 Application 213032
Type ANDA
Sponsor SUNSHINE LAKE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 25MG BASE No No 002 SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 50MG BASE No No 003 SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 100MG BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A213032-001 SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-11 A213032-002 SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-06-11 A213032-003 SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-06-11
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 3 · 111 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 2026-02-19 14:30 UTC 2026-02 A213032-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213032-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-06-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213032-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-06-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213032-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213032-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-06-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213032-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-06-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213032-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213032-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-06-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213032-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-06-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213032-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213032-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-06-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213032-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-06-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213032-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213032-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-06-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213032-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-06-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213032-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213032-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-06-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213032-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-06-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213032-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213032-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-06-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213032-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-06-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213032-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213032-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-06-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213032-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-06-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213032-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213032-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-06-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213032-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-06-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213032-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213032-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-06-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213032-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-06-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213032-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213032-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-06-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213032-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-06-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213032-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213032-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-06-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213032-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-06-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213032-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213032-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-06-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213032-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-06-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213032-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-11 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 111 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 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 48792-7911 Sildenafil Sildenafil Sunshine Lake Pharma Co., Ltd ANDA Current 48792-7912 Sildenafil Sildenafil Sunshine Lake Pharma Co., Ltd ANDA Current 48792-7913 Sildenafil Sildenafil Sunshine Lake Pharma Co., Ltd ANDA Current