Home Applications 078380 Application 078380
Type ANDA
Sponsor TEVA PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 20MG BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A078380-001 SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL 2013-01-07
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 · 42 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 2026-08-18 06:07:40 2026-07 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL 2013-01-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 e64feba35796…
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 20 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0093-5517 Sildenafil Sildenafil Teva Pharmaceuticals USA, Inc. ANDA Current 0093-5517 Sildenafil Sildenafil Teva Pharmaceuticals USA, Inc. ANDA Current 0093-5517 Sildenafil Sildenafil Teva Pharmaceuticals USA, Inc. ANDA Current 0093-5517 Sildenafil Sildenafil Teva Pharmaceuticals USA, Inc. ANDA Current 0093-5517 Sildenafil Sildenafil Teva Pharmaceuticals USA, Inc. ANDA Current 43063-668 Sildenafil Sildenafil PD-Rx Pharmaceuticals, Inc. ANDA Current 43063-668 Sildenafil Sildenafil PD-Rx Pharmaceuticals, Inc. ANDA Current 43063-668 Sildenafil Sildenafil PD-Rx Pharmaceuticals, Inc. ANDA Current 43063-668 Sildenafil Sildenafil PD-Rx Pharmaceuticals, Inc. ANDA Current 43063-668 Sildenafil Sildenafil PD-Rx Pharmaceuticals, Inc. ANDA Current 50090-2618 Sildenafil Sildenafil A-S Medication Solutions ANDA Current 50090-2618 Sildenafil Sildenafil A-S Medication Solutions ANDA Current 50436-5517 Sildenafil Sildenafil Unit Dose Services ANDA Current 53002-1719 Sildenafil Sildenafil RPK Pharmaceuticals, Inc. ANDA Current 53002-1719 Sildenafil Sildenafil RPK Pharmaceuticals, Inc. ANDA Current 68071-3137 Sildenafil Sildenafil NuCare Pharmaceuticals, Inc. ANDA Current 70934-208 Sildenafil Sildenafil Denton Pharma, Inc. DBA Northwind Pharmaceuticals ANDA Current 71205-509 Sildenafil Sildenafil Proficient Rx LP ANDA Current 71335-0288 Sildenafil Sildenafil Bryant Ranch Prepack ANDA Current 71335-0288 Sildenafil Sildenafil Bryant Ranch Prepack ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 9152 ORIG 2007-08-14