Home Applications 076574 Application 076574
Type ANDA
Sponsor TELIGENT PHARMA INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ECONAZOLE NITRATE ECONAZOLE NITRATE CREAM;TOPICAL 1% 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 A076574-001 ECONAZOLE NITRATE ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2004-12-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076574-001 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 · 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 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2004-12-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL 2004-12-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL 2004-12-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL 2004-12-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL 2004-12-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL 2004-12-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL 2004-12-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL 2004-12-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL 2004-12-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL 2004-12-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL 2004-12-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL 2004-12-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL 2004-12-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL 2004-12-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL 2004-12-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2004-12-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2004-12-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2004-12-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2004-12-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2004-12-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2004-12-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2004-12-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2004-12-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2004-12-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2004-12-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2004-12-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2004-12-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2004-12-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL 2004-12-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL 2004-12-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL 2004-12-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL 2004-12-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL 2004-12-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL 2004-12-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL 2004-12-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2004-12-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2004-12-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2004-12-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2004-12-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076574-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2004-12-17 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 · 15 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 52565-022 Econazole Nitrate Econazole Nitrate Teligent Pharma, Inc. ANDA Current 52565-022 Econazole Nitrate Econazole Nitrate Teligent Pharma, Inc. ANDA Current 52565-022 Econazole Nitrate Econazole Nitrate Teligent Pharma, Inc. ANDA Current 59088-745 Econasil Econasil PURETEK CORPORATION ANDA Current 59088-752 Zolpak Econazole Nitrate PureTek Corporation ANDA Current 63739-085 Econazole Nitrate Econazole Nitrate McKesson Corporation ANDA Current 68788-7406 Econazole Nitrate Econazole Nitrate Preferred Pharmaceuticals Inc. ANDA Current 68788-7406 Econazole Nitrate Econazole Nitrate Preferred Pharmaceuticals Inc. ANDA Current 68788-7406 Econazole Nitrate Econazole Nitrate Preferred Pharmaceuticals Inc. ANDA Current 68788-7406 Econazole Nitrate Econazole Nitrate Preferred Pharmaceuticals Inc. ANDA Current 68788-7406 Econazole Nitrate Econazole Nitrate Preferred Pharmaceuticals Inc. ANDA Current 70512-029 Econazole Nitrate Econazole Nitrate SOLA Pharmaceuticals ANDA Current 70512-029 Econazole Nitrate Econazole Nitrate SOLA Pharmaceuticals ANDA Current 70512-029 Econazole Nitrate Econazole Nitrate SOLA Pharmaceuticals ANDA Current 72275-735 Econavix Econazole Nitrate Primary Pharmaceuticals, Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 43088 ORIG 2008-07-31