Application 084394

Type: ANDA
Sponsor: ACTAVIS MID ATLANTIC

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
A084394-001	SELENIUM SULFIDE	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		Approved before 1982

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	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	A084394-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A084394-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A084394-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084394-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084394-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084394-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084394-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084394-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084394-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084394-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084394-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084394-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084394-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084394-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084394-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084394-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084394-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084394-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084394-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084394-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084394-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084394-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084394-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084394-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084394-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084394-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084394-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084394-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084394-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084394-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084394-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084394-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084394-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084394-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084394-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084394-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084394-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084394-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084394-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084394-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	Approved before 1982	`f41ea6bd6efb…`

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 · 43 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Head and Shoulders 2in1 Clinical Strength Dry Scalp Rescue	SELENIUM SULFIDE	The Procter & Gamble Manufacturing Company	2d041983-5750-e0f1-e063-6394a90a5b9e	2025-01-31	Warnings	Name fallback generic name: SELENIUM SULFIDE
Head and Shoulders Clinical Strength Advanced Oil Control	SELENIUM SULFIDE	The Procter & Gamble Manufacturing Company	2ccaceed-9928-ef05-e063-6394a90a6511	2025-01-28	Warnings	Name fallback generic name: SELENIUM SULFIDE
Meijer Medicated Selenium Sulfide Anti-Dandruff	SELENIUM SULFIDE	Meijer Distribution, Inc	41b563c6-5df6-4ead-bddf-a69a07970ea0	2025-01-14	Warnings	Name fallback generic name: SELENIUM SULFIDE
NATURALTECH PURIFYING ANTI-DANDRUFF	SELENIUM SULFIDE	Davines S.p.A.	369a24fd-3882-4fad-b57a-45806090aff1	2024-12-11	Warnings	Name fallback generic name: SELENIUM SULFIDE
Hairitage Wash It Away Anti-Dandruff for Oily, Flaky Scalp	SELENIUM SULFIDE	Maesa, LLC.	b09c3b0d-564e-45e4-b6ff-c1f0c12a9521	2024-11-13	Warnings	Name fallback generic name: SELENIUM SULFIDE
Hairitage Wash It Away Anti-Dandruff for Dry, Flaky Scalp	SELENIUM SULFIDE	Maesa, LLC.	fa5d4ee3-fbeb-4379-bbd3-2b5b2cc45430	2024-11-12	Warnings	Name fallback generic name: SELENIUM SULFIDE
Equate Medicated Dandruff Anti-Dandruff	SELENIUM SULFIDE	Wal-Mart Stores, Inc.	3afbdc09-622d-4681-a6fb-8429a0a3df39	2024-11-07	Warnings	Name fallback generic name: SELENIUM SULFIDE
Walgreens Dandruff and Conditioner Cleansing and Conditioning Anti-dandruff	SELENIUM SULFIDE	Walgreen Company	dbcaeae8-4680-41d8-84e2-896183d2121d	2024-11-01	Warnings	Name fallback generic name: SELENIUM SULFIDE
Walgreens Dandruff Maximum Strength Anti-dandruff	SELENIUM SULFIDE	Walgreen Company	0187b034-44d7-4b84-af04-d018bc9750f3	2024-11-01	Warnings	Name fallback generic name: SELENIUM SULFIDE
FAMILY Wellness MAXIMUM STRENGTH DANDRUFF Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis	SELENIUM SULFIDE	FAMILY DOLLAR SERVICES INC	41a808e1-67a7-4b29-8ec4-d6c13cf62243	2024-10-21	Warnings	Name fallback generic name: SELENIUM SULFIDE
CVS Health MAXIMUM STRENGTH Dandruff Anti-Seborrheic Dermatitis, anti-dandruff	SELENIUM SULFIDE	CVS Health	cff51af6-84de-4ba5-ac99-9bc42a65c9a5	2024-09-24	Warnings	Name fallback generic name: SELENIUM SULFIDE
up and up Moisturizing Anti-dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis	SELENIUM SULFIDE	TARGET CORPORATION	e315b2d8-304d-4807-9594-9286e9b642ef	2024-05-10	Warnings	Name fallback generic name: SELENIUM SULFIDE
Walgreens Clinical Strength Medicated Dandruff Anti-dandruff, Anti-seborrheic dermatitis	SELENIUM SULFIDE	Walgreen Company	cc83427d-49e6-4a20-9d03-9ec8ce27e487	2024-05-09	Warnings	Name fallback generic name: SELENIUM SULFIDE
meijer MEDICATED selenium sulfide Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis	SELENIUM SULFIDE	Meijer Distribution, Inc	c8dee061-3362-400f-aa59-93ec0b8125ba	2024-05-01	Warnings	Name fallback generic name: SELENIUM SULFIDE
Walgreens Dandruff With Menthol/Selenium Sulfide Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis	SELENIUM SULFIDE	Walgreen Company	70c7b400-a295-4b99-8673-e6a38343d76f	2024-05-01	Warnings	Name fallback generic name: SELENIUM SULFIDE
up and up Medicated Anti-dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis	SELENIUM SULFIDE	TARGET CORPORATION	a516282f-ed6b-4e94-b269-ea34f700dd69	2024-04-25	Warnings	Name fallback generic name: SELENIUM SULFIDE
Rugby Anti-Dandruff	SELENIUM SULFIDE	Rugby Laboratories	f8942f2b-32fb-4a2d-b0cf-0f2d1c6974c2	2024-03-14	Warnings	Name fallback generic name: SELENIUM SULFIDE
Leader Medicated Dandruff Anti-Seborrheic Dermatitis, Anti-Dandruff	SELENIUM SULFIDE	Cardinal Health, 110 dba LEADER	3f64a2ef-a415-49b0-bf14-eb4da66d511f	2024-03-13	Warnings	Name fallback generic name: SELENIUM SULFIDE
amazon basics maximum strength dandruff Anti-dandruff	SELENIUM SULFIDE	AMAZON.COM SERVICES LLC	194e4c51-ff7b-4def-a71d-efa5dfca3efd	2024-02-26	Warnings	Name fallback generic name: SELENIUM SULFIDE
Prosoria Medicated	SELENIUM SULFIDE	Nuvothera, Inc.	44eaaeb0-1400-4697-85d0-e8c2282c1cba	2024-01-11	Warnings	Name fallback generic name: SELENIUM SULFIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.