Application 212215

Type: ANDA
Sponsor: TARO PHARMA USA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TAVABOROLE	TAVABOROLE	SOLUTION;TOPICAL	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
A212215-001	TAVABOROLE	TAVABOROLE	5%	SOLUTION / TOPICAL			2021-05-07

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	A212215-001	TAVABOROLE	5%	SOLUTION / TOPICAL		2021-05-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212215-001	TAVABOROLE	5%	SOLUTION / TOPICAL		2021-05-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212215-001	TAVABOROLE	5%	SOLUTION / TOPICAL		2021-05-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212215-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2021-05-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212215-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2021-05-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212215-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2021-05-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212215-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2021-05-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212215-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2021-05-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212215-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2021-05-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212215-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2021-05-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212215-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2021-05-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212215-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2021-05-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212215-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2021-05-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212215-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2021-05-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212215-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2021-05-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212215-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2021-05-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212215-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2021-05-07	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212215-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2021-05-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212215-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2021-05-07	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212215-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2021-05-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212215-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2021-05-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212215-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2021-05-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212215-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2021-05-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212215-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2021-05-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212215-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2021-05-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212215-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2021-05-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212215-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2021-05-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212215-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2021-05-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212215-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2021-05-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212215-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2021-05-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212215-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2021-05-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212215-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2021-05-07	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212215-001	TAVABOROLE	5%	SOLUTION / TOPICAL		2021-05-07	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212215-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212215-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212215-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212215-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212215-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212215-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212215-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212215-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212215-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212215-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212215-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212215-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212215-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212215-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212215-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212215-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212215-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212215-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212215-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212215-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212215-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212215-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212215-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212215-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212215-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212215-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212215-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212215-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212215-001	AB	1	`cb3db0bc1861…`

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
TAVABOROLE	TAVABOROLE	Cipla USA Inc.	37004451-0345-4e00-96be-f05db600fb9f	2025-12-19	Adverse reactions	Name fallback brand name: TAVABOROLE generic name: TAVABOROLE
Tavaborole	TAVABOROLE TOPICAL SOLUTION, 5%	Encube Ethicals, Inc.	050f5d10-5591-426e-9020-6516b3363304	2025-09-15	Adverse reactions	Name fallback brand name: Tavaborole
Tavaborole	TAVABOROLE	Alembic Pharmaceuticals Limited	6da415c6-a9be-42bf-829f-e72ccc5fe3ba	2025-02-18	Adverse reactions	Name fallback brand name: Tavaborole generic name: TAVABOROLE
Tavaborole	TAVABOROLE	Viona Pharmaceuticals Inc	c13610c8-c57a-4519-b37d-eb4fbdcec398	2024-12-06	Adverse reactions	Name fallback brand name: Tavaborole generic name: TAVABOROLE
Tavaborole	TAVABOROLE	Zydus Lifesciences Limited	15bc62dc-4f5e-4d43-a125-d1f00bee84a5	2024-12-06		Name fallback brand name: Tavaborole generic name: TAVABOROLE
tavaborole	TAVABOROLE	Mayne Pharma Commercial LLC	7ad9dc39-7501-4db5-a935-d9be8eea30a6	2024-03-05	Adverse reactions	Name fallback brand name: tavaborole generic name: TAVABOROLE
Tavaborole	TAVABOROLE	Alembic Pharmaceuticals Inc.	22a6617b-d4b1-405e-901a-0b39a7b2837d	2023-12-15	Adverse reactions	Name fallback brand name: Tavaborole generic name: TAVABOROLE
Tavaborole	TAVABOROLE	Chartwell RX, LLC	7fe75d38-80a0-444e-84bc-4087b45a791e	2023-09-15	Adverse reactions	Name fallback brand name: Tavaborole generic name: TAVABOROLE
Tavaborole	TAVABOROLE	Amneal Pharmaceuticals NY LLC	c7f19812-3811-4a3a-9909-43a7a7f134d4	2019-06-15	Adverse reactions	Name fallback brand name: Tavaborole generic name: TAVABOROLE

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51672-1397	TAVABOROLE	TAVABOROLE	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
61132	ORIG	2019-12-03