Application 020404

Type: NDA
Sponsor: MYLAN PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
003	AVITA	TRETINOIN	CREAM;TOPICAL	0.025%	No	No

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
N020404-003	AVITA	TRETINOIN	0.025%	CREAM / TOPICAL	AB		1997-01-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020404-003	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`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	N020404-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020404-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020404-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020404-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020404-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020404-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020404-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020404-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020404-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020404-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020404-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020404-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020404-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020404-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020404-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020404-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020404-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020404-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020404-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020404-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020404-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020404-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020404-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020404-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020404-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020404-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020404-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020404-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020404-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020404-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020404-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020404-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020404-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020404-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020404-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020404-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020404-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020404-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020404-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020404-003	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tretinoin	TRETINOIN	Actavis Pharma, Inc.	b5e385a2-f6f9-41cb-8a33-eedba397043f	2024-12-11	Adverse reactions	Exact identifier application applno (NDA): 020404 application number: NDA020404 ndc (product): 0472-0117
Tretinoin	TRETINOIN	A-S Medication Solutions	c7860dcd-91b0-44e0-98d6-a843b16457e1	2023-10-25	Adverse reactions	Exact identifier application applno (NDA): 020404 application number: NDA020404 ndc (product): 50090-0651

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-6141	Avita	tretinoin	Mylan Pharmaceuticals Inc.	NDA	Current
0378-6141	Avita	tretinoin	Mylan Pharmaceuticals Inc.	NDA	Current
0472-0117	Tretinoin	Tretinoin	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0472-0117	Tretinoin	Tretinoin	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0472-0117	Tretinoin	Tretinoin	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0472-0117	Tretinoin	Tretinoin	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
50090-0651	Tretinoin	Tretinoin	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-0651	Tretinoin	Tretinoin	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-0651	Tretinoin	Tretinoin	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-0651	Tretinoin	Tretinoin	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
53002-8100	Tretinoin	Tretinoin	RPK Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
59088-800	Tretinopak	tretinoin, avobenzone, octinoxate, octisalate and titanium dioxide	PureTek Corporation	NDA AUTHORIZED	Current
59088-800	Tretinopak	tretinoin, avobenzone, octinoxate, octisalate and titanium dioxide	PureTek Corporation	NDA AUTHORIZED GENERIC	Current