Home Applications 212260 Application 212260
Type ANDA
Sponsor NOVITIUM PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SILDENAFIL CITRATE SILDENAFIL CITRATE FOR SUSPENSION;ORAL EQ 10MG BASE/ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212260-001 SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-05-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212260-001 AB
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 · 43 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 A212260-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-05-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A212260-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-05-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212260-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-05-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212260-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-05-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212260-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-05-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212260-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-05-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212260-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-05-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212260-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-05-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212260-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-05-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212260-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-05-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212260-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-05-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212260-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-05-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212260-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-05-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212260-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-05-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212260-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-05-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212260-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-05-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212260-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-05-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212260-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-05-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212260-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-05-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A212260-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-05-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A212260-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-05-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212260-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-05-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212260-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-05-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A212260-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-05-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A212260-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-05-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A212260-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-05-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A212260-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-05-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A212260-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-05-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A212260-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-05-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212260-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-05-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212260-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-05-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212260-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-05-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212260-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-05-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212260-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-05-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212260-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-05-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212260-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-05-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212260-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-05-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212260-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-05-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212260-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-05-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212260-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-05-31 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2019-12-13 00:20 UTC 2019-12 A212260-001 CGT 2019-11-27 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 A212260-001 CGT 2019-11-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A212260-001 CGT 2019-11-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A212260-001 CGT 2019-11-27 ea99ee380514…
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.
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 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 70954-168 Sildenafil Sildenafil citrate Novitium Pharma LLC ANDA Current 70954-168 Sildenafil Sildenafil citrate Novitium Pharma LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 59125 ORIG 2019-06-19