Application 207133

Type: ANDA
Sponsor: PERRIGO UK FINCO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLURANDRENOLIDE	FLURANDRENOLIDE	LOTION;TOPICAL	0.05%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A207133-001	FLURANDRENOLIDE	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL	AT		2016-08-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL	AT		2016-08-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL	AT		2016-08-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL	AT		2016-08-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL	AT		2016-08-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL	AT		2016-08-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL	AT		2016-08-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL	AT		2016-08-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL	AT		2016-08-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL	AT		2016-08-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL	AT		2016-08-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL	AT		2016-08-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL	AT		2016-08-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL	AT		2016-08-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL	AT		2016-08-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL	AT		2016-08-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL	AT		2016-08-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL	AT		2016-08-30	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207133-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207133-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207133-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207133-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207133-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207133-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207133-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207133-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207133-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207133-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207133-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207133-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207133-001	AT	1	`ea99ee380514…`
2023-05-13 08:27 UTC	2023-05	A207133-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207133-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207133-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207133-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207133-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207133-001	AT	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Flurandrenolide	FLURANDRENOLIDE	Bryant Ranch Prepack	2718df54-7dc1-4ebc-8258-607bedcf5813	2023-08-17	Adverse reactions	Exact identifier application applno (ANDA): 207133 application number: ANDA207133
Flurandrenolide	FLURANDRENOLIDE	Bryant Ranch Prepack	3868377d-bee3-42f4-8c72-319e84e7d5bd	2023-07-17	Adverse reactions	Exact identifier application applno (ANDA): 207133 application number: ANDA207133 ndc (product): 63629-8657
Flurandrenolide	FLURANDRENOLIDE	Padagis Israel Pharmaceuticals Ltd	9c4f5aea-2e08-400c-88f6-d9e3013afda7	2022-10-11	Adverse reactions	Exact identifier application applno (ANDA): 207133 application number: ANDA207133 ndc (product): 45802-928

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45802-928	Flurandrenolide	Flurandrenolide	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-928	Flurandrenolide	Flurandrenolide	Perrigo New York Inc	ANDA	Current
45802-928	Flurandrenolide	Flurandrenolide	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
63629-8657	Flurandrenolide	Flurandrenolide	Bryant Ranch Prepack	ANDA	Current
63629-8657	Flurandrenolide	Flurandrenolide	Bryant Ranch Prepack	ANDA	Current
63629-8657	Flurandrenolide	Flurandrenolide	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
45189	ORIG	2016-08-30