Home Applications 020985 Application 020985
Type NDA
Sponsor VALEANT PHARMS NORTH Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CARAC FLUOROURACIL CREAM;TOPICAL 0.5% Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N020985-001 CARAC FLUOROURACIL 0.5% CREAM / TOPICAL RLD, RS 2000-10-27
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 · 41 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 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020985-001 CARAC 0.5% CREAM / TOPICAL AB RLD, RS 2000-10-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020985-001 CARAC 0.5% CREAM / TOPICAL AB RLD, RS 2000-10-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020985-001 CARAC 0.5% CREAM / TOPICAL AB RLD, RS 2000-10-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020985-001 CARAC 0.5% CREAM / TOPICAL AB RLD, RS 2000-10-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020985-001 CARAC 0.5% CREAM / TOPICAL AB RLD, RS 2000-10-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020985-001 CARAC 0.5% CREAM / TOPICAL AB RLD, RS 2000-10-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N020985-001 6670335 2021-06-02 U-68 Drug product 74a2ff9319b5…2021-12-28 21:50 UTC 2021-12 N020985-001 6670335 2021-06-02 U-68 Drug product 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020985-001 6670335 2021-06-02 U-68 Drug product 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020985-001 6670335 2021-06-02 U-68 Drug product 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020985-001 6670335 2021-06-02 U-68 Drug product 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020985-001 6670335 2021-06-02 U-68 Drug product c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020985-001 6670335 2021-06-02 U-68 Drug product 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020985-001 6670335 2021-06-02 U-68 Drug product b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020985-001 6670335 2021-06-02 U-68 Drug product 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join FLUOROURACIL FLUOROURACIL CREAM, 0.5% Dr. Reddy's Laboratories Inc. 37dcfb83-0e7d-d23d-9cd5-afa5bdc30628 2025-07-11 Warnings, Adverse reactions Exact identifier application applno (NDA): 020985 application number: NDA020985
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0187-5200 Carac fluorouracil Bausch Health US LLC NDA Current 0187-5200 Carac fluorouracil Bausch Health Americas, Inc. NDA Current 0187-5200 Carac fluorouracil Bausch Health US, LLC NDA Current 0187-5200 Carac fluorouracil Valeant Pharmaceuticals North America LLC NDA Current 0378-8078 Fluorouracil Cream fluorouracil Mylan Pharmaceuticals Inc. NDA Current 0378-8078 Fluorouracil Cream fluorouracil Mylan Pharmaceuticals Inc. NDA AUTHORIZED GENERIC Current 0378-8078 Fluorouracil Cream fluorouracil Mylan Pharmaceuticals Inc. NDA AUTHORIZED GENERIC Current 0378-8078 Fluorouracil Cream fluorouracil Mylan Pharmaceuticals Inc. NDA Current 0378-8078 Fluorouracil Cream fluorouracil Mylan Pharmaceuticals Inc. NDA Current 66530-258 Fluorouracil fluorouracil Spear Dermatology Products Inc NDA AUTHORIZED GENERIC Current 66530-258 Fluorouracil fluorouracil Spear Dermatology Products Inc NDA AUTHORIZED GENERIC Current 66530-258 Fluorouracil fluorouracil Spear Dermatology Products Inc NDA AUTHORIZED GENERIC Current
Documents# Document, Submission type, Date table Document Submission type Date 85814 SUPPL 2026-05-04 85813 SUPPL 2026-05-04 71161 SUPPL 2022-05-27 71157 SUPPL 2022-05-27 14086 SUPPL 2003-12-29 26376 SUPPL 2003-12-19 41861 ORIG 2003-04-25 35787 ORIG 2000-10-27 26375 ORIG 2000-10-27