Application 209411

Type: ANDA
Sponsor: TELIGENT PHARMA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLOBETASOL PROPIONATE (EMOLLIENT)	CLOBETASOL PROPIONATE	CREAM;TOPICAL	0.05%	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
A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB2		2017-08-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209411-001	AB2

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	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL		2017-08-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL		2017-08-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL		2017-08-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL		2017-08-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL		2017-08-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL		2017-08-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL		2017-08-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL		2017-08-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL		2017-08-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL		2017-08-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL		2017-08-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL		2017-08-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209411-001	CLOBETASOL PROPIONATE (EMOLLIENT)	0.05%	CREAM / TOPICAL	AB2	2017-08-21	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209411-001	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209411-001	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209411-001	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209411-001	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209411-001	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209411-001	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209411-001	AB2	1	`2680178bc6a6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209411-001	AB2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209411-001	AB2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209411-001	AB2	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209411-001	AB2	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209411-001	AB2	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209411-001	AB2	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209411-001	AB2	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209411-001	AB2	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209411-001	AB2	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209411-001	AB2	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209411-001	AB2	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209411-001	AB2	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209411-001	AB2	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209411-001	AB2	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209411-001	AB2	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209411-001	AB2	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209411-001	AB2	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209411-001	AB2	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209411-001	AB2	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209411-001	AB2	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209411-001	AB2	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209411-001	AB2	1	`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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clobetasol Propionate (emollient)	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	cb0bc057-d6ab-4eea-af7a-01661ae9b517	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209411 application number: ANDA209411
Clobetasol Propionate (emollient)	CLOBETASOL PROPIONATE	The J. Molner Company LLC	26ccb1d8-c466-e238-e063-6394a90a0069	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209411 application number: ANDA209411

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52565-094	Clobetasol Propionate (emollient)	clobetasol propionate	Teligent Pharma, Inc.	ANDA	Current
52565-094	Clobetasol Propionate (emollient)	clobetasol propionate	Teligent Pharma, Inc.	ANDA	Current
63739-064	Clobetasol Propionate	Clobetasol Propionate	McKesson Corporation	ANDA	Current