Home Applications 201156 Application 201156
Type ANDA
Sponsor JUBILANT GENERICS 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 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 A201156-001 SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2024-12-20 A201156-002 SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2024-12-20 A201156-003 SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2024-12-20
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.
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 A201156-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2024-12-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A201156-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2024-12-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A201156-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2024-12-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A201156-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2024-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201156-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2024-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201156-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2024-12-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A201156-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2024-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201156-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2024-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201156-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2024-12-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201156-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2024-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201156-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2024-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201156-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2024-12-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201156-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2024-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201156-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2024-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201156-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2024-12-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201156-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2024-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201156-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2024-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201156-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2024-12-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201156-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2024-12-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201156-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2024-12-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201156-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2024-12-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201156-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2024-12-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201156-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2024-12-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201156-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2024-12-20 03ed91905a0d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A201156-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2024-12-20 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A201156-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2024-12-20 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A201156-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2024-12-20 a50c72e98297…
Observed Orange Book normalized TE history# 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 Sildenafil SILDENAFIL Jubilant Cadista Pharmaceuticals Inc. 1ed2420b-478a-ca9c-0330-85c845acdd32 2026-08-03 Warnings, Adverse reactions Exact identifier application applno (ANDA): 201156 application number: ANDA201156
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.