Application 211303

Type: ANDA
Sponsor: ENCUBE ETHICALS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PERMETHRIN	PERMETHRIN	CREAM;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
A211303-001	PERMETHRIN	PERMETHRIN	5%	CREAM / TOPICAL	AB		2019-04-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A211303-001	AB

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 · 41 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
2026-02-19 14:30 UTC	2026-02	A211303-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	2019-04-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211303-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	2019-04-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211303-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	2019-04-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211303-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	2019-04-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211303-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	2019-04-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211303-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	2019-04-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211303-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	2019-04-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211303-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	2019-04-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211303-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	2019-04-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211303-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	2019-04-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211303-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	2019-04-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211303-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	2019-04-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211303-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	2019-04-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211303-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	2019-04-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211303-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	2019-04-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211303-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	2019-04-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211303-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	2019-04-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211303-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	2019-04-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211303-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	2019-04-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211303-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	2019-04-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211303-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	2019-04-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211303-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	2019-04-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211303-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	2019-04-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211303-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	2019-04-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211303-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	2019-04-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211303-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	2019-04-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211303-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	2019-04-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211303-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	2019-04-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211303-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	2019-04-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211303-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	2019-04-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211303-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	2019-04-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211303-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	2019-04-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211303-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	2019-04-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211303-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	2019-04-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211303-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	2019-04-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211303-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	2019-04-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211303-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	2019-04-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211303-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	2019-04-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211303-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	2019-04-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211303-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	2019-04-03	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211303-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211303-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211303-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211303-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211303-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211303-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211303-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211303-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211303-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211303-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211303-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211303-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211303-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211303-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211303-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211303-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211303-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211303-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211303-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211303-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211303-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211303-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211303-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211303-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211303-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211303-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211303-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211303-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211303-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211303-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211303-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211303-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211303-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211303-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211303-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211303-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211303-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211303-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211303-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211303-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Permethrin	PERMETHRIN CREAM 5% W/W	REMEDYREPACK INC.	e3d77092-dad6-4df5-ac39-ff9dc8f5758c	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211303 application number: ANDA211303 ndc (product): 70518-2945
Permethrin	PERMETHRIN CREAM 5% W/W	Encube Ethicals, Inc.	35225d0a-3bde-4c7d-bdf9-81661012e77c	2025-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211303 application number: ANDA211303 ndc (product): 21922-021
Permethrin	PERMETHRIN CREAM 5% W/W	Preferred Pharmaceuticals Inc.	d0d6b1ac-2f3a-433b-ba2b-832be3e0f93f	2025-09-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211303 application number: ANDA211303
Permethrin	PERMETHRIN 5% W/W	A-S Medication Solutions	694abbf9-9460-4c55-b8c7-66220cabb5b6	2023-11-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211303 application number: ANDA211303 ndc (product): 50090-5888

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21922-021	Permethrin	Permethrin Cream 5% w/w	Encube Ethicals Private Limited	ANDA	Current
21922-021	Permethrin	Permethrin Cream 5% w/w	Encube Ethicals Private Limited	ANDA	Current
50090-5888	Permethrin	Permethrin 5% w/w	A-S Medication Solutions	ANDA	Current
53002-9571	Permethrin	Permethrin 5% w/w	RPK Pharmaceuticals, Inc.	ANDA	Current
68071-1627	Permethrin	Permethrin Cream 5% w/w	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1627	Permethrin	Permethrin Cream 5% w/w	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-2945	Permethrin	Permethrin Cream 5% w/w	REMEDYREPACK INC.	ANDA	Current
70518-2945	Permethrin	Permethrin Cream 5% w/w	REMEDYREPACK INC.	ANDA	Current
70518-2945	Permethrin	Permethrin Cream 5% w/w	REMEDYREPACK INC.	ANDA	Current