Application 076498

Type: ANDA
Sponsor: ZO SKIN HEALTH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRETINOIN	TRETINOIN	CREAM;TOPICAL	0.05%	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
A076498-001	TRETINOIN	TRETINOIN	0.05%	CREAM / TOPICAL			2005-09-15

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	A076498-001	TRETINOIN	0.05%	CREAM / TOPICAL		2005-09-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076498-001	TRETINOIN	0.05%	CREAM / TOPICAL		2005-09-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076498-001	TRETINOIN	0.05%	CREAM / TOPICAL		2005-09-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076498-001	TRETINOIN	0.05%	CREAM / TOPICAL		2005-09-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076498-001	TRETINOIN	0.05%	CREAM / TOPICAL		2005-09-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076498-001	TRETINOIN	0.05%	CREAM / TOPICAL		2005-09-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076498-001	TRETINOIN	0.05%	CREAM / TOPICAL		2005-09-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076498-001	TRETINOIN	0.05%	CREAM / TOPICAL		2005-09-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076498-001	TRETINOIN	0.05%	CREAM / TOPICAL		2005-09-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076498-001	TRETINOIN	0.05%	CREAM / TOPICAL		2005-09-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076498-001	TRETINOIN	0.05%	CREAM / TOPICAL		2005-09-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076498-001	TRETINOIN	0.05%	CREAM / TOPICAL		2005-09-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076498-001	TRETINOIN	0.05%	CREAM / TOPICAL		2005-09-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076498-001	TRETINOIN	0.05%	CREAM / TOPICAL		2005-09-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076498-001	TRETINOIN	0.05%	CREAM / TOPICAL		2005-09-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076498-001	TRETINOIN	0.05%	CREAM / TOPICAL		2005-09-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076498-001	TRETINOIN	0.05%	CREAM / TOPICAL		2005-09-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076498-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB2	2005-09-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076498-001	TRETINOIN	0.05%	CREAM / TOPICAL		2005-09-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076498-001	TRETINOIN	0.05%	CREAM / TOPICAL		2005-09-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076498-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB2	2005-09-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076498-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB2	2005-09-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076498-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB2	2005-09-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076498-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB2	2005-09-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076498-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB2	2005-09-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076498-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB2	2005-09-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076498-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB2	2005-09-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076498-001	TRETINOIN	0.05%	CREAM / TOPICAL		2005-09-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076498-001	TRETINOIN	0.05%	CREAM / TOPICAL		2005-09-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076498-001	TRETINOIN	0.05%	CREAM / TOPICAL		2005-09-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076498-001	TRETINOIN	0.05%	CREAM / TOPICAL		2005-09-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076498-001	TRETINOIN	0.05%	CREAM / TOPICAL		2005-09-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076498-001	TRETINOIN	0.05%	CREAM / TOPICAL		2005-09-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076498-001	TRETINOIN	0.05%	CREAM / TOPICAL		2005-09-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076498-001	TRETINOIN	0.05%	CREAM / TOPICAL		2005-09-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076498-001	TRETINOIN	0.05%	CREAM / TOPICAL		2005-09-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076498-001	TRETINOIN	0.05%	CREAM / TOPICAL		2005-09-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076498-001	TRETINOIN	0.05%	CREAM / TOPICAL		2005-09-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076498-001	TRETINOIN	0.05%	CREAM / TOPICAL		2005-09-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076498-001	TRETINOIN	0.05%	CREAM / TOPICAL		2005-09-15	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A076498-001	AB2	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076498-001	AB2	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076498-001	AB2	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076498-001	AB2	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076498-001	AB2	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076498-001	AB2	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076498-001	AB2	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076498-001	AB2	1	`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 1 of 3 · 59 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tretinoin	TRETINOIN	Redpharm Drug	57d1e8ed-ffc8-5e19-e063-6294a90af941	2026-07-30	Warnings, Adverse reactions	Name fallback brand name: Tretinoin generic name: TRETINOIN
Tretinoin	TRETINOIN	Alembic Pharmaceuticals Limited	5304df69-5d29-48f5-8227-80c7a6f12e6d	2026-07-01	Adverse reactions	Name fallback brand name: Tretinoin generic name: TRETINOIN
Tretinoin	TRETINOIN	Alembic Pharmaceuticals Inc.	49e542a3-57cc-482f-9118-4174c80742dd	2026-06-26	Adverse reactions	Name fallback brand name: Tretinoin generic name: TRETINOIN
Tretinoin	TRETINOIN	Major Pharmaceuticals	045258e2-5efb-4147-bf74-4c43af04dccc	2026-05-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tretinoin generic name: TRETINOIN
Tretinoin	TRETINOIN	Amneal Pharmaceuticals NY LLC	4b6006e3-f7a4-4823-8217-3e5b0f7e58d9	2026-04-29	Warnings, Adverse reactions	Name fallback brand name: Tretinoin generic name: TRETINOIN
TRETINOIN	TRETINOIN	Encube Ethicals, Inc.	57558405-42fa-40bb-a61c-48e030d976de	2026-04-16	Warnings, Adverse reactions	Name fallback brand name: TRETINOIN generic name: TRETINOIN
TRETINOIN	TRETINOIN	REMEDYREPACK INC.	c4d5155b-046d-4f94-bafc-651b572c2bd5	2026-04-07	Warnings, Adverse reactions	Name fallback brand name: TRETINOIN generic name: TRETINOIN
Tretinoin	TRETINOIN	Encube Ethicals, Inc.	5e3fb8ea-234c-4be2-95a7-d139e069cf98	2026-03-31	Warnings, Adverse reactions	Name fallback brand name: Tretinoin generic name: TRETINOIN
Tretinoin	TRETINOIN	Par Health USA, LLC	9c4ae9d9-c2a0-4995-a27a-e3f0f0284db9	2026-03-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tretinoin generic name: TRETINOIN
Tretinoin	TRETINOIN	Bryant Ranch Prepack	2b58cf56-e713-4cdd-8b4e-e6651ef76650	2026-03-04	Warnings, Adverse reactions	Name fallback brand name: Tretinoin generic name: TRETINOIN
Renova	TRETINOIN	Bausch Health US LLC	9f0a0e8d-1051-48a4-80c5-1bd260dd9c36	2026-02-24	Warnings, Adverse reactions	Name fallback generic name: TRETINOIN
Tretinoin	TRETINOIN	A-S Medication Solutions	44be2556-1ea9-49e9-86dd-991fbcc6348d	2026-02-02	Warnings, Adverse reactions	Name fallback brand name: Tretinoin generic name: TRETINOIN
Tretinoin	TRETINOIN	Glenmark Pharmaceuticals Inc., USA	264138c1-9e5f-45ef-be87-79ca97c989d9	2026-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tretinoin generic name: TRETINOIN
TRETINOIN	TRETINOIN	Preferred Pharmaceuticals Inc.	d6819051-4748-479e-8b53-c298edcbd410	2026-01-28	Warnings, Adverse reactions	Name fallback brand name: TRETINOIN generic name: TRETINOIN
Tretinoin	TRETINOIN	Alembic Pharmaceuticals Inc.	872b3f8f-c073-4808-a106-840188ac7a00	2026-01-23	Adverse reactions	Name fallback brand name: Tretinoin generic name: TRETINOIN
TRETINOIN	TRETINOIN	NuCare Pharmaceuticals,Inc.	47fc341b-8cff-9d63-e063-6394a90abdfd	2026-01-09	Warnings, Adverse reactions	Name fallback brand name: TRETINOIN generic name: TRETINOIN
Tretinoin	TRETINOIN	American Health Packaging	b22d5a07-623a-4645-b87d-a151b86da8d5	2025-10-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tretinoin generic name: TRETINOIN
Tretinoin	TRETINOIN	Bryant Ranch Prepack	04f14d6e-5b44-44bd-a7f3-d684d9c5d7cb	2025-10-21	Adverse reactions	Name fallback brand name: Tretinoin generic name: TRETINOIN
Tretinoin	TRETINOIN	Bryant Ranch Prepack	a1ae0000-3411-47e5-94f2-ae2ee70eadfb	2025-10-21	Adverse reactions	Name fallback brand name: Tretinoin generic name: TRETINOIN
TRETINOIN	TRETINOIN	Bryant Ranch Prepack	8929196c-389a-4c43-843c-00fbb26a1dd9	2025-10-17	Warnings, Adverse reactions	Name fallback brand name: TRETINOIN generic name: TRETINOIN

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42851-011	Tretinoin (Emollient)	Tretinoin	ZO Skin Health, Inc.	ANDA	Current
42851-011	Tretinoin (Emollient)	Tretinoin	ZO Skin Health, Inc.	ANDA	Current
42851-012	Refissa Tretinoin (Emollient)	Tretinoin	ZO Skin Health, Inc.	ANDA	Current
42851-012	Refissa Tretinoin (Emollient)	Tretinoin	ZO Skin Health, Inc.	ANDA	Current
42851-012	Refissa Tretinoin (Emollient)	Tretinoin	ZO Skin Health, Inc.	ANDA	Current
50224-002	Refissa	Tretinoin	Suneva Medical, Inc.	ANDA	Current
50224-002	REFISSA	TRETINOIN	Suneva Medical, Inc.	ANDA	Current