Application 088228

Type: ANDA
Sponsor: WOCKHARDT BIO AG

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SELENIUM SULFIDE	SELENIUM SULFIDE	LOTION/SHAMPOO;TOPICAL	2.5%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A088228-001	SELENIUM SULFIDE	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL			1983-09-01

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 · 43 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
2026-09-14 22:38:34	2026-08	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	AT	1983-09-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	AT	1983-09-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	AT	1983-09-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	AT	1983-09-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	AT	1983-09-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	AT	1983-09-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	AT	1983-09-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	AT	1983-09-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	AT	1983-09-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	AT	1983-09-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	AT	1983-09-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	AT	1983-09-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	AT	1983-09-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088228-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088228-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088228-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088228-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088228-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088228-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088228-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088228-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088228-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088228-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088228-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088228-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088228-001	AT	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 · 43 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dermoia Seborrheic Dermatitis Selenium Sulfide	SELENIUM SULFIDE	TREASUREWISE LLC	04b8532e-44a7-4eaf-a46d-87611ec93c24	2026-06-23	Warnings	Name fallback generic name: SELENIUM SULFIDE
Silvagle Selenium Sulfide Anti DandruffShampoo	SELENIUM SULFIDE	GUANGZHOU BAOSIJIE BIOTECHNOLOGY CO., LTD	54885ae3-7e2f-7bd2-e063-6394a90a97fe	2026-06-18	Warnings	Name fallback generic name: SELENIUM SULFIDE
CVS Health MAXIMUM STRENGTH Dandruff Medicated Anti-Seborrheic Dermatitis, anti-dandruff	SELENIUM SULFIDE	CVS Health	307e4b16-10ab-44f4-86b9-709d10566d4c	2026-06-04	Warnings	Name fallback generic name: SELENIUM SULFIDE
CVS Gold	SELENIUM SULFIDE	Apollo Health and Beauty Care	1d12ca6a-2734-0534-e063-6294a90a2706	2026-05-08	Warnings	Name fallback generic name: SELENIUM SULFIDE
Dandruff	SELENIUM SULFIDE	H E B	182ca790-0713-412a-9111-c0cf40f20d02	2026-02-24	Warnings, Adverse reactions	Name fallback generic name: SELENIUM SULFIDE
Dandruff	SELENIUM SULFIDE	Meijer, Inc.	c0e4f8cb-74fc-4c0d-9721-f87aa2aa1992	2026-02-19	Warnings, Adverse reactions	Name fallback generic name: SELENIUM SULFIDE
Selsun Blue 2-in-1	SELENIUM SULFIDE	Chattem, Inc.	f97e458c-cce3-498f-81fc-1b96a4e8f50a	2026-02-18	Warnings	Name fallback generic name: SELENIUM SULFIDE
Head and Shoulders Clinical Strength Dandruff Defense Intensive Itch Relief	SELENIUM SULFIDE	The Procter & Gamble Manufacturing Company	b6ad7707-9d02-31a6-e053-2a95a90ae7ad	2025-12-31	Warnings	Name fallback generic name: SELENIUM SULFIDE
Head and Shoulders 2in1 Clinical Strength Dandruff Defense Intensive Itch Relief	SELENIUM SULFIDE	The Procter & Gamble Manufacturing Company	b6ada541-f12b-76f2-e053-2a95a90a5286	2025-12-31	Warnings	Name fallback generic name: SELENIUM SULFIDE
SELENIUM SULFIDE	SELENIUM SULFIDE	KMM Pharmaceuticals, LLC	d9165c56-4c78-8d5a-e053-2995a90a6b2e	2025-12-18	Warnings, Adverse reactions	Name fallback brand name: SELENIUM SULFIDE generic name: SELENIUM SULFIDE
Head and Shoulders Clinical Strength Dandruff Defense Dry Scalp Rescue	SELENIUM SULFIDE	The Procter & Gamble Manufacturing Company	b69c4d1f-379f-be92-e053-2995a90ab7ad	2025-12-16	Warnings	Name fallback generic name: SELENIUM SULFIDE
Selenium Sulfide	SELENIUM SULFIDE	Laser Pharmaceuticals, LLC	a72001ce-42a2-4708-e053-2995a90a7593	2025-11-06	Warnings, Adverse reactions	Name fallback brand name: Selenium Sulfide generic name: SELENIUM SULFIDE
Selenium Sulfide	SELENIUM SULFIDE	Laser Pharmaceuticals, LLC	dc6609b4-1757-3a13-e053-2995a90ac172	2025-11-06	Warnings, Adverse reactions	Name fallback brand name: Selenium Sulfide generic name: SELENIUM SULFIDE
Head and Shoulders Clinical Strength Cooling Itch Relief	SELENIUM SULFIDE	The Procter & Gamble Manufacturing Company	40464e2d-f738-33ec-e063-6394a90a02c2	2025-10-03	Warnings	Name fallback generic name: SELENIUM SULFIDE
Head and Shoulders 2in1 Clinical Strength Cooling Itch Relief	SELENIUM SULFIDE	The Procter & Gamble Manufacturing Company	4046c345-e1ac-0ecc-e063-6294a90a59fa	2025-10-03	Warnings	Name fallback generic name: SELENIUM SULFIDE
Head and Shoulders Clinical Strength Dandruff Defense Advanced Oil Control	SELENIUM SULFIDE	The Procter & Gamble Manufacturing Company	b6ad107b-024b-828f-e053-2995a90aae36	2025-09-04	Warnings	Name fallback generic name: SELENIUM SULFIDE
SELENIUM SULFIDE	SELENIUM SULFIDE	Cintex Services, LLC	3999e3e3-1c1b-bcf7-e063-6394a90aed50	2025-07-10	Warnings, Adverse reactions	Name fallback brand name: SELENIUM SULFIDE generic name: SELENIUM SULFIDE
SELENIUM SULFIDE	SELENIUM SULFIDE	Padagis Israel Pharmaceuticals Ltd	28b84e3c-ae44-40bb-93c4-2625e19f7e61	2025-05-31	Warnings, Adverse reactions	Name fallback brand name: SELENIUM SULFIDE generic name: SELENIUM SULFIDE
Selenium Sulfide	SELENIUM SULFIDE	Westminster Pharmaceuticals, LLC	9fcab751-28f4-485a-aa37-169318a61110	2025-04-23	Warnings, Adverse reactions	Name fallback brand name: Selenium Sulfide generic name: SELENIUM SULFIDE
Head and Shoulders Clinical Strength Dry Scalp Rescue	SELENIUM SULFIDE	The Procter & Gamble Manufacturing Company	3272a482-3813-63e4-e063-6394a90a43eb	2025-04-10	Warnings	Name fallback generic name: SELENIUM SULFIDE

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-2166	Selenium Sulfide	Selenium Sulfide	A-S Medication Solutions	ANDA	Current
50090-2166	SELENIUM SULFIDE	selenium sulfide	A-S Medication Solutions	ANDA	Current
60432-528	SELENIUM SULFIDE	selenium sulfide	Morton Grove Pharmaceuticals, Inc.	ANDA	Current
76413-123	Selenium Sulfide	Selenium Sulfide	Central Texas Community Health Centers	ANDA	Current