Application 022070

Type: NDA
Sponsor: DOW PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ATRALIN	TRETINOIN	GEL;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
N022070-001	ATRALIN	TRETINOIN	0.05%	GEL / TOPICAL	AB	RLD, RS	2007-07-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N022070-001	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 · 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	N022070-001	ATRALIN	0.05%	GEL / TOPICAL	AB	RLD, RS	2007-07-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022070-001	ATRALIN	0.05%	GEL / TOPICAL	AB	RLD, RS	2007-07-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022070-001	ATRALIN	0.05%	GEL / TOPICAL	AB	RLD, RS	2007-07-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022070-001	ATRALIN	0.05%	GEL / TOPICAL	AB	RLD, RS	2007-07-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022070-001	ATRALIN	0.05%	GEL / TOPICAL	AB	RLD, RS	2007-07-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022070-001	ATRALIN	0.05%	GEL / TOPICAL	AB	RLD, RS	2007-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022070-001	ATRALIN	0.05%	GEL / TOPICAL	AB	RLD, RS	2007-07-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022070-001	ATRALIN	0.05%	GEL / TOPICAL	AB	RLD, RS	2007-07-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022070-001	ATRALIN	0.05%	GEL / TOPICAL	AB	RLD, RS	2007-07-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022070-001	ATRALIN	0.05%	GEL / TOPICAL	AB	RLD, RS	2007-07-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022070-001	ATRALIN	0.05%	GEL / TOPICAL	AB	RLD, RS	2007-07-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022070-001	ATRALIN	0.05%	GEL / TOPICAL	AB	RLD, RS	2007-07-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022070-001	ATRALIN	0.05%	GEL / TOPICAL	AB	RLD, RS	2007-07-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022070-001	ATRALIN	0.05%	GEL / TOPICAL	AB	RLD, RS	2007-07-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022070-001	ATRALIN	0.05%	GEL / TOPICAL	AB	RLD, RS	2007-07-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022070-001	ATRALIN	0.05%	GEL / TOPICAL	AB	RLD, RS	2007-07-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022070-001	ATRALIN	0.05%	GEL / TOPICAL	AB	RLD, RS	2007-07-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022070-001	ATRALIN	0.05%	GEL / TOPICAL	AB	RLD, RS	2007-07-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022070-001	ATRALIN	0.05%	GEL / TOPICAL	AB	RLD, RS	2007-07-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022070-001	ATRALIN	0.05%	GEL / TOPICAL	AB	RLD, RS	2007-07-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022070-001	ATRALIN	0.05%	GEL / TOPICAL	AB	RLD, RS	2007-07-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022070-001	ATRALIN	0.05%	GEL / TOPICAL	AB	RLD, RS	2007-07-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022070-001	ATRALIN	0.05%	GEL / TOPICAL	AB	RLD, RS	2007-07-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022070-001	ATRALIN	0.05%	GEL / TOPICAL	AB	RLD, RS	2007-07-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022070-001	ATRALIN	0.05%	GEL / TOPICAL	AB	RLD, RS	2007-07-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022070-001	ATRALIN	0.05%	GEL / TOPICAL	AB	RLD, RS	2007-07-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022070-001	ATRALIN	0.05%	GEL / TOPICAL	AB	RLD, RS	2007-07-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022070-001	ATRALIN	0.05%	GEL / TOPICAL	AB	RLD, RS	2007-07-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022070-001	ATRALIN	0.05%	GEL / TOPICAL	AB	RLD, RS	2007-07-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022070-001	ATRALIN	0.05%	GEL / TOPICAL	AB	RLD, RS	2007-07-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022070-001	ATRALIN	0.05%	GEL / TOPICAL	AB	RLD, RS	2007-07-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022070-001	ATRALIN	0.05%	GEL / TOPICAL	AB	RLD, RS	2007-07-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022070-001	ATRALIN	0.05%	GEL / TOPICAL	AB	RLD, RS	2007-07-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022070-001	ATRALIN	0.05%	GEL / TOPICAL	AB	RLD, RS	2007-07-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022070-001	ATRALIN	0.05%	GEL / TOPICAL	AB	RLD, RS	2007-07-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022070-001	ATRALIN	0.05%	GEL / TOPICAL	AB	RLD, RS	2007-07-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022070-001	ATRALIN	0.05%	GEL / TOPICAL	AB	RLD, RS	2007-07-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022070-001	ATRALIN	0.05%	GEL / TOPICAL	AB	RLD, RS	2007-07-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022070-001	ATRALIN	0.05%	GEL / TOPICAL	AB	RLD, RS	2007-07-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022070-001	ATRALIN	0.05%	GEL / TOPICAL	AB	RLD, RS	2007-07-26	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022070-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022070-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022070-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022070-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022070-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022070-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022070-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022070-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022070-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022070-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022070-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022070-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022070-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022070-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022070-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022070-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022070-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022070-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022070-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022070-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022070-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022070-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022070-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022070-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022070-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022070-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022070-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022070-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022070-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022070-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022070-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022070-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022070-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022070-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022070-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022070-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022070-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022070-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022070-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022070-001	AB	1	`cb3db0bc1861…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tretinoin	TRETINOIN	Oceanside Pharmaceuticals	febda58b-c9ee-4b95-bee7-dca5f2645f98	2024-02-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022070 application number: NDA022070 ndc (product): 68682-800
Atralin	TRETINOIN	Bausch Health US, LLC	b6b45969-a64a-4ce3-b3b6-157d2568a301	2024-02-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022070 application number: NDA022070 ndc (product): 13548-070
Tretinoin	TRETINOIN	Obagi Cosmeceuticals LLC	c5ee36ac-2ffd-4cca-ad47-b1dae7ebdb3b	2021-05-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022070 application number: NDA022070 ndc (product): 62032-413

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13548-070	Atralin	Tretinoin	Coria Laboratories	NDA	Current
13548-070	Atralin	Tretinoin	Bausch Health US, LLC	NDA	Current
62032-413	Tretinoin	Tretinoin	Obagi Cosmeceuticals LLC	NDA AUTHORIZED GENERIC	Current
62032-413	Tretinoin	Tretinoin	Obagi Cosmeceuticals LLC	NDA AUTHORIZED GENERIC	Current
62032-413	Tretinoin	Tretinoin	Obagi Cosmeceuticals LLC	NDA AUTHORIZED GENERIC	Current
62032-413	Tretinoin	Tretinoin	Obagi Cosmeceuticals LLC	NDA AUTHORIZED GENERIC	Current
68682-800	Tretinoin	Tretinoin	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-800	Tretinoin	Tretinoin	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
29201	SUPPL	2014-09-03
16892	SUPPL	2014-09-03
21925	ORIG	2009-03-05
38188	ORIG	2007-07-30
6821	ORIG	2007-07-30