Home Applications 209353 Application 209353
Type NDA
Sponsor DOW PHARM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ALTRENO TRETINOIN LOTION;TOPICAL 0.05% 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 N209353-001 ALTRENO TRETINOIN 0.05% LOTION / TOPICAL RLD, RS 2018-08-23
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 N209353-001 11324710 2038-08-22 U-2368 2022-06-08
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 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 2 · 72 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209353-001 11324710 2038-08-22 U-2368 2022-06-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209353-001 11324710 2038-08-22 U-2368 2022-06-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209353-001 11324710 2038-08-22 U-2368 2022-06-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209353-001 11324710 2038-08-22 U-2368 2022-06-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209353-001 11324710 2038-08-22 U-2368 2022-06-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209353-001 11324710 2038-08-22 U-2368 2022-06-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209353-001 11324710 2038-08-22 U-2368 2022-06-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209353-001 11324710 2038-08-22 U-2368 2022-06-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209353-001 11324710 2038-08-22 U-2368 2022-06-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N209353-001 11324710 2038-08-22 U-2368 2022-06-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209353-001 11324710 2038-08-22 U-2368 2022-06-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209353-001 11324710 2038-08-22 U-2368 2022-06-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209353-001 11324710 2038-08-22 U-2368 2022-06-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N209353-001 11324710 2038-08-22 U-2368 2022-06-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209353-001 11324710 2038-08-22 U-2368 2022-06-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209353-001 6517847 2020-08-03 U-2368 Drug product 2018-08-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209353-001 6517847 2020-08-03 U-2368 Drug product 2018-08-30 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209353-001 6517847 2020-08-03 U-2368 Drug product 2018-08-30 c0c555d07b60…
Observed Orange Book exclusivity 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 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0187-0005 Altreno tretinoin Valeant Pharmaceuticals North America LLC NDA Current 0187-0005 Altreno tretinoin Bausch Health US, LLC NDA Current 0187-0005 Altreno tretinoin Bausch Health Americas, Inc. NDA Current 0187-0005 Altreno tretinoin Bausch Health Americas, Inc. NDA Current 0187-0005 Altreno tretinoin Valeant Pharmaceuticals North America LLC NDA Current 0187-0005 Altreno tretinoin Bausch Health US, LLC NDA Current 0187-0005 Altreno tretinoin Bausch Health Americas, Inc. NDA Current 0187-0005 Altreno tretinoin Valeant Pharmaceuticals North America LLC NDA Current 0187-0005 Altreno tretinoin Bausch Health Americas, Inc. NDA Current 0187-0005 Altreno tretinoin Bausch Health US, LLC NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 57806 ORIG 2019-02-25 55304 ORIG 2018-08-24 55284 ORIG 2018-08-24