Application 210720

Type: ANDA
Sponsor: TARO

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 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
A210720-001	IVERMECTIN	IVERMECTIN	0.5%	LOTION / TOPICAL			2020-05-06

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	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL	AB	2020-05-06	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2020-11-12 02:37 UTC	2020-11	A210720-001	AB	1	`c0c555d07b60…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A210720-001	PC	2021-05-29	`782e0a99824c…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ivermectin	IVERMECTIN	AmerisourceBergen	4e924212-cd7b-ccd9-e063-6394a90afb95	2026-04-16	Warnings	Exact identifier application applno (ANDA): 210720 application number: ANDA210720
Ivermectin	IVERMECTIN	Sun Pharmaceutical Industries, Inc.	dd2c66e6-bd50-46df-a335-26215d02d13b	2025-12-22	Warnings	Exact identifier application applno (ANDA): 210720 application number: ANDA210720 ndc (product): 51672-4230
Ivermectin	IVERMECTIN	CVS Pharmacy	326e85c6-b95f-6aa8-e063-6294a90a4985	2025-06-20	Warnings	Exact identifier application applno (ANDA): 210720 application number: ANDA210720
RID One and Done	IVERMECTIN	Oystershell Consumer Health, Inc.	731a15f8-3578-4a95-b04c-aa6cf44a4665	2025-03-07	Warnings	Exact identifier application applno (ANDA): 210720 application number: ANDA210720
Ivermectin	IVERMECTIN	WALMART INC.	1608ec4a-2af4-4a43-a83f-5b25937068d1	2025-01-09	Warnings	Exact identifier application applno (ANDA): 210720 application number: ANDA210720 ndc (product): 79903-154
Ivermectin	IVERMECTIN	Belmora LLC	0d405318-3db5-41b6-a248-a6c1cfe7a765	2024-10-17	Warnings	Exact identifier application applno (ANDA): 210720 application number: ANDA210720
Ivermectin	IVERMECTIN	Rite Aid Corporation	3a2eb7f3-b72b-435c-a609-ce7050cccff4	2024-08-12	Warnings	Exact identifier application applno (ANDA): 210720 application number: ANDA210720 ndc (product): 11822-4230
Ivermectin	IVERMECTIN	Walgreen Company	b8e1d919-ba66-4dc0-b0fc-cfb3a229dad9	2022-01-04	Warnings	Exact identifier application applno (ANDA): 210720 application number: ANDA210720 ndc (product): 0363-4230
Ivermectin	IVERMECTIN	CVS Pharmacy	15f1fe25-8ac4-486c-926d-86da187f5efc	2021-12-30	Warnings	Exact identifier application applno (ANDA): 210720 application number: ANDA210720 ndc (product): 51316-423

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
0363-4230	Ivermectin	Ivermectin	Walgreen Company	ANDA	Current
11822-4230	Ivermectin	Ivermectin	Rite Aid Corporation	ANDA	Current
51316-423	Ivermectin	Ivermectin	CVS Pharmacy	ANDA	Current
51672-4211	Ivermectin	Ivermectin	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4230	Ivermectin	Ivermectin	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4230	Ivermectin	Ivermectin	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
79903-154	Ivermectin	Ivermectin	WALMART INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
54785	ORIG	2018-07-06