Application 212485

Type: ANDA
Sponsor: TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IVERMECTIN	IVERMECTIN	LOTION;TOPICAL	0.5%	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
A212485-001	IVERMECTIN	IVERMECTIN	0.5%	LOTION / TOPICAL			2022-03-21

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A212485-001	IVERMECTIN	0.5%	LOTION / TOPICAL	2022-03-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212485-001	IVERMECTIN	0.5%	LOTION / TOPICAL	2022-03-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212485-001	IVERMECTIN	0.5%	LOTION / TOPICAL	2022-03-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212485-001	IVERMECTIN	0.5%	LOTION / TOPICAL	2022-03-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212485-001	IVERMECTIN	0.5%	LOTION / TOPICAL	2022-03-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212485-001	IVERMECTIN	0.5%	LOTION / TOPICAL	2022-03-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212485-001	IVERMECTIN	0.5%	LOTION / TOPICAL	2022-03-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212485-001	IVERMECTIN	0.5%	LOTION / TOPICAL	2022-03-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212485-001	IVERMECTIN	0.5%	LOTION / TOPICAL	2022-03-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212485-001	IVERMECTIN	0.5%	LOTION / TOPICAL	2022-03-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212485-001	IVERMECTIN	0.5%	LOTION / TOPICAL	2022-03-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212485-001	IVERMECTIN	0.5%	LOTION / TOPICAL	2022-03-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212485-001	IVERMECTIN	0.5%	LOTION / TOPICAL	2022-03-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212485-001	IVERMECTIN	0.5%	LOTION / TOPICAL	2022-03-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212485-001	IVERMECTIN	0.5%	LOTION / TOPICAL	2022-03-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212485-001	IVERMECTIN	0.5%	LOTION / TOPICAL	2022-03-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212485-001	IVERMECTIN	0.5%	LOTION / TOPICAL	2022-03-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212485-001	IVERMECTIN	0.5%	LOTION / TOPICAL	2022-03-21	`5d02ea3f76ae…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212485-001	IVERMECTIN	0.5%	LOTION / TOPICAL	2022-03-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212485-001	IVERMECTIN	0.5%	LOTION / TOPICAL	2022-03-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212485-001	IVERMECTIN	0.5%	LOTION / TOPICAL	2022-03-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212485-001	IVERMECTIN	0.5%	LOTION / TOPICAL	2022-03-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212485-001	IVERMECTIN	0.5%	LOTION / TOPICAL	2022-03-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212485-001	IVERMECTIN	0.5%	LOTION / TOPICAL	2022-03-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212485-001	IVERMECTIN	0.5%	LOTION / TOPICAL	2022-03-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212485-001	IVERMECTIN	0.5%	LOTION / TOPICAL	2022-03-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212485-001	IVERMECTIN	0.5%	LOTION / TOPICAL	2022-03-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212485-001	IVERMECTIN	0.5%	LOTION / TOPICAL	2022-03-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212485-001	IVERMECTIN	0.5%	LOTION / TOPICAL	2022-03-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212485-001	IVERMECTIN	0.5%	LOTION / TOPICAL	2022-03-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212485-001	IVERMECTIN	0.5%	LOTION / TOPICAL	2022-03-21	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212485-001	IVERMECTIN	0.5%	LOTION / TOPICAL	2022-03-21	`a50c72e98297…`

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 2 · 35 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ivermectin	IVERMECTIN	YYBA Corp	59ea9767-2e0b-ebc2-e063-6294a90ab904	2026-08-25	Warnings	Name fallback brand name: Ivermectin generic name: IVERMECTIN
Ivermectin	IVERMECTIN	Azurity Pharmaceuticals, Inc.	58c9cc4d-b1f3-1b6f-e063-6294a90ab597	2026-08-11	Warnings	Name fallback brand name: Ivermectin generic name: IVERMECTIN
Head Lice Treatment Ivermectin Lotion118mL	IVERMECTIN	Yunqi Cosmetics (Shenzhen) Co., Ltd	56a37d8f-c1b8-465a-e063-6394a90aa334	2026-07-15	Warnings	Name fallback generic name: IVERMECTIN
SYNTHABIO Ivermectin	IVERMECTIN	Shenzhen Xuyan Technology Co., Ltd.	540d6a24-68bf-50c8-e063-6294a90aaa30	2026-06-22	Warnings	Name fallback generic name: IVERMECTIN
Ivermectin	IVERMECTIN	AmerisourceBergen	4e924212-cd7b-ccd9-e063-6394a90afb95	2026-04-16	Warnings	Name fallback brand name: Ivermectin generic name: IVERMECTIN
Ivermectin	IVERMECTIN	Ajanta Pharma USA Inc.	1fb17bc2-9192-4a0b-a3ee-fda9db035daa	2026-04-09	Warnings, Adverse reactions	Name fallback brand name: Ivermectin generic name: IVERMECTIN
Ivermectin	IVERMECTIN	A-S Medication Solutions	104a5045-94b1-4022-bc49-719521f30f0d	2026-03-03	Warnings, Adverse reactions	Name fallback brand name: Ivermectin generic name: IVERMECTIN
Ivermectin	IVERMECTIN	Viona Pharmaceuticals Inc	2de5ee45-0465-4996-ac00-5bdd352b4ed7	2026-02-27	Warnings, Adverse reactions	Name fallback brand name: Ivermectin generic name: IVERMECTIN
Ivermectin	IVERMECTIN	Zydus Lifesciences Limited	6d626814-5288-441c-9508-f7f5130feceb	2026-02-27		Name fallback brand name: Ivermectin generic name: IVERMECTIN
Ivermectin	IVERMECTIN	Sun Pharmaceutical Industries, Inc.	dd2c66e6-bd50-46df-a335-26215d02d13b	2025-12-22	Warnings	Name fallback brand name: Ivermectin generic name: IVERMECTIN
Ivermectin	IVERMECTIN	Edenbridge Pharmaceuticals LLC.	847a1dd7-d65b-4a0e-a67d-d90392059dac	2025-12-18	Warnings, Adverse reactions	Name fallback brand name: Ivermectin generic name: IVERMECTIN
lice treatment dedicated	IVERMECTIN	Shenzhen Zhenshangzekai Technology Co., Ltd.	459879fb-efd1-9fc1-e063-6394a90a98b0	2025-12-10	Warnings	Name fallback generic name: IVERMECTIN
ivometn ivermectin lice treatment	IVERMECTIN	Shenzhen Zhenshangzekai Technology Co., Ltd.	459b4316-89df-0bb1-e063-6294a90a518d	2025-12-10	Warnings	Name fallback generic name: IVERMECTIN
Ivermectin	IVERMECTIN	Bryant Ranch Prepack	1061e454-d1dc-4293-b18d-9c8717fbbb40	2025-10-23	Adverse reactions	Name fallback brand name: Ivermectin generic name: IVERMECTIN
Ivermectin	IVERMECTIN	CVS Pharmacy	326e85c6-b95f-6aa8-e063-6294a90a4985	2025-06-20	Warnings	Name fallback brand name: Ivermectin generic name: IVERMECTIN
Ivermectin	IVERMECTIN	Actavis Pharma, Inc.	de9253c3-7d66-47fe-8ad7-8c0d4ee8ebda	2025-05-31	Adverse reactions	Name fallback brand name: Ivermectin generic name: IVERMECTIN
RID One and Done	IVERMECTIN	Oystershell Consumer Health, Inc.	731a15f8-3578-4a95-b04c-aa6cf44a4665	2025-03-07	Warnings	Name fallback generic name: IVERMECTIN
Ivermectin	IVERMECTIN	Advagen Pharma Ltd	e88adfbc-e375-4fea-827e-6ec51ed6fd0a	2025-01-29	Warnings, Adverse reactions	Name fallback brand name: Ivermectin generic name: IVERMECTIN
Ivermectin	IVERMECTIN	WALMART INC.	1608ec4a-2af4-4a43-a83f-5b25937068d1	2025-01-09	Warnings	Name fallback brand name: Ivermectin generic name: IVERMECTIN
IVERMECTIN	IVERMECTIN	DR. REDDY'S LABORATORIES, INC.	4cb062d7-0597-4e92-b2f6-7129a95e9500	2024-11-19	Warnings, Adverse reactions	Name fallback brand name: IVERMECTIN generic name: IVERMECTIN

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
61138	ORIG	2019-12-04