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 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
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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N209353-001	ALTRENO	0.05%	LOTION / TOPICAL	RLD, RS	2018-08-23	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N209353-001	ALTRENO	0.05%	LOTION / TOPICAL	RLD, RS	2018-08-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209353-001	ALTRENO	0.05%	LOTION / TOPICAL	RLD, RS	2018-08-23	`caaa826d4ba7…`
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…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N209353-001	10653656	2038-08-22	U-2368	Drug product	2020-05-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209353-001	11324710	2038-08-22	U-2368		2022-06-08	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N209353-001	10653656	2038-08-22	U-2368	Drug product	2020-05-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209353-001	11324710	2038-08-22	U-2368		2022-06-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209353-001	10653656	2038-08-22	U-2368	Drug product	2020-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209353-001	11324710	2038-08-22	U-2368		2022-06-08	`caaa826d4ba7…`
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…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N209353-001	NDF	2021-08-23	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N209353-001	NDF	2021-08-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209353-001	NDF	2021-08-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209353-001	NDF	2021-08-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209353-001	NDF	2021-08-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209353-001	NDF	2021-08-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209353-001	NDF	2021-08-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209353-001	NDF	2021-08-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209353-001	NDF	2021-08-23	`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 2 of 3 · 57 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tretinoin	TRETINOIN	Oceanside Pharmaceuticals	d3c528d2-429d-4f37-9ebf-eee8b9fd3050	2025-09-30	Warnings, Adverse reactions	Name fallback generic name: TRETINOIN
TRETINOIN	TRETINOIN	Encube Ethicals, Inc.	b61f6b02-6171-4da8-94eb-bcd4808dd918	2025-09-16	Warnings, Adverse reactions	Name fallback generic name: TRETINOIN
Tretinoin	TRETINOIN	Alembic Pharmaceuticals Limited	4e96fb71-14f4-4789-91af-ba94b0879162	2025-09-16	Adverse reactions	Name fallback generic name: TRETINOIN
Tretinoin	TRETINOIN	NuCare Pharmaceuticals,Inc.	3deccf35-67ad-9cbc-e063-6394a90a7ee9	2025-09-03	Warnings, Adverse reactions	Name fallback generic name: TRETINOIN
Tretinoin	TRETINOIN	NuCare Pharmaceuticals,Inc.	3ded762b-5fe6-c5ef-e063-6294a90ad602	2025-09-03	Warnings, Adverse reactions	Name fallback generic name: TRETINOIN
Retin-A MICRO	TRETINOIN	Bausch Health US LLC	08ab7e0c-1437-455f-815c-98904d96a289	2025-09-01	Warnings, Adverse reactions	Name fallback generic name: TRETINOIN
Tretinoin	TRETINOIN	A-S Medication Solutions	da206984-4ded-4d5c-8a23-323920466a5f	2025-07-23	Warnings, Adverse reactions	Name fallback generic name: TRETINOIN
Tretinoin	TRETINOIN	NORTHSTAR RX LLC	2e508351-eca3-427e-8d16-e840a84db0f5	2025-07-09	Warnings, Adverse reactions	Name fallback generic name: TRETINOIN
Tretinoin	TRETINOIN	NORTHSTAR RX LLC	de3e7308-1212-4727-b541-568a84dac48a	2025-07-09	Warnings, Adverse reactions	Name fallback generic name: TRETINOIN
Tretinoin	TRETINOIN	Sun Pharmaceutical Industries, Inc.	9e964be5-8d67-46a8-888e-0351f9113f68	2025-07-02	Warnings, Adverse reactions	Name fallback generic name: TRETINOIN
Tretinoin	TRETINOIN	Sun Pharmaceutical Industries, Inc.	2b0c8ee4-83a5-48f1-809a-9716131f7290	2025-07-02	Warnings, Adverse reactions	Name fallback generic name: TRETINOIN
Tretinoin	TRETINOIN	Aurobindo Pharma Limited	dea325b5-3cb8-4ffb-84e9-782f0e3f6b0e	2025-06-19	Warnings, Adverse reactions	Name fallback generic name: TRETINOIN
Tretinoin	TRETINOIN	Aurobindo Pharma Limited	f64e45d7-bbc0-4da4-9ccb-e3941f22fdbe	2025-06-18	Warnings, Adverse reactions	Name fallback generic name: TRETINOIN
Tretinoin	TRETINOIN	NuCare Pharmaceuticals,Inc.	373dd14d-061a-4408-e063-6394a90abf95	2025-06-10	Warnings, Adverse reactions	Name fallback generic name: TRETINOIN
Tretinoin	TRETINOIN	Sun Pharmaceutical Industries, Inc.	2a31b13b-5cc8-4f6a-b364-872f6a478025	2025-05-27	Warnings, Adverse reactions	Name fallback generic name: TRETINOIN
Tretinoin	TRETINOIN	NORTHSTAR RX LLC	c0212b19-0676-4546-bc5d-682c089e7b7d	2025-05-27	Warnings, Adverse reactions	Name fallback generic name: TRETINOIN
Tretinoin	TRETINOIN	Alembic Pharmaceuticals Limited	7845d60d-7c4c-4854-a417-6d3ea86a710f	2025-04-25	Adverse reactions	Name fallback generic name: TRETINOIN
Tretinoin	TRETINOIN	Preferred Pharmaceuticals Inc.	fda88f47-21b3-4678-ab21-befb03035730	2025-04-11	Warnings, Adverse reactions	Name fallback generic name: TRETINOIN
Tretinoin	TRETINOIN	NuCare Pharmaceuticals, Inc.	31d2794a-ca4b-246a-e063-6394a90a1954	2025-04-02	Warnings, Adverse reactions	Name fallback generic name: TRETINOIN
Tretinoin	TRETINOIN	NuCare Pharmaceuticals, Inc.	31d2cd00-e534-6755-e063-6394a90ab8bb	2025-04-02	Warnings, Adverse reactions	Name fallback generic name: TRETINOIN

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 · 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