Home Applications 021753 Application 021753
Type NDA
Sponsor GALDERMA LABS LP Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DIFFERIN ADAPALENE GEL;TOPICAL 0.3% Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 N021753-001 DIFFERIN ADAPALENE 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021753-001 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 · 44 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 2026-10-15 13:18:30 2026-09 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 c2088c7a36db…2026-09-14 22:38:34 2026-08 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
Observed Orange Book patent history# Patent history page 2 of 5 · 170 observed states.
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 N021753-001 7834060 2023-03-12 U-1078 2010-11-19 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021753-001 7838558 2023-03-12 Drug product 2010-11-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021753-001 7868044 2023-03-12 U-1078 2011-01-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021753-001 8703820 2023-03-12 U-1078 2014-05-21 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021753-001 7737181 2024-08-29 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021753-001 7579377 2025-02-23 U-818 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021753-001 7834060 2023-03-12 U-1078 2010-11-19 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021753-001 7838558 2023-03-12 Drug product 2010-11-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021753-001 7868044 2023-03-12 U-1078 2011-01-12 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021753-001 8703820 2023-03-12 U-1078 2014-05-21 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021753-001 7737181 2024-08-29 Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021753-001 7579377 2025-02-23 U-818 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021753-001 7834060 2023-03-12 U-1078 2010-11-19 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021753-001 7838558 2023-03-12 Drug product 2010-11-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021753-001 7868044 2023-03-12 U-1078 2011-01-12 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021753-001 8703820 2023-03-12 U-1078 2014-05-21 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021753-001 7737181 2024-08-29 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021753-001 7579377 2025-02-23 U-818 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021753-001 7834060 2023-03-12 U-1078 2010-11-19 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021753-001 7838558 2023-03-12 Drug product 2010-11-30 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021753-001 7868044 2023-03-12 U-1078 2011-01-12 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021753-001 8703820 2023-03-12 U-1078 2014-05-21 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021753-001 7737181 2024-08-29 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021753-001 7579377 2025-02-23 U-818 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021753-001 7834060 2023-03-12 U-1078 2010-11-19 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021753-001 7838558 2023-03-12 Drug product 2010-11-30 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021753-001 7868044 2023-03-12 U-1078 2011-01-12 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021753-001 8703820 2023-03-12 U-1078 2014-05-21 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021753-001 7737181 2024-08-29 Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021753-001 7579377 2025-02-23 U-818 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021753-001 7834060 2023-03-12 U-1078 2010-11-19 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021753-001 7838558 2023-03-12 Drug product 2010-11-30 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021753-001 7868044 2023-03-12 U-1078 2011-01-12 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021753-001 8703820 2023-03-12 U-1078 2014-05-21 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021753-001 7737181 2024-08-29 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021753-001 7579377 2025-02-23 U-818 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021753-001 7834060 2023-03-12 U-1078 2010-11-19 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021753-001 7838558 2023-03-12 Drug product 2010-11-30 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021753-001 7868044 2023-03-12 U-1078 2011-01-12 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021753-001 8703820 2023-03-12 U-1078 2014-05-21 c0c555d07b60…
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 · 2 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 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0299-5918 DIFFERIN adapalene Galderma Laboratories, L.P. NDA Current 0299-5918 DIFFERIN adapalene Galderma Laboratories, L.P. NDA Current 0299-5918 DIFFERIN adapalene Galderma Laboratories, L.P. NDA Current 66993-884 ADAPALENE ADAPALENE Prasco Laboratories NDA AUTHORIZED GENERIC Current 69007-918 adapalene adapalene Owen Laboratories, Inc. NDA AUTHORIZED GENERIC Current
Documents# Document, Submission type, Date table Document Submission type Date 77173 SUPPL 2024-01-02 77172 SUPPL 2024-01-02 77168 SUPPL 2023-12-29 77167 SUPPL 2023-12-29 71943 SUPPL 2022-08-29 71898 SUPPL 2022-08-26 28527 SUPPL 2014-06-18 16313 SUPPL 2012-02-27 37588 SUPPL 2010-09-07 28526 SUPPL 2010-09-07 42299 ORIG 2008-03-14 6125 ORIG 2007-07-05 16312 ORIG 2007-06-27