Application 211207

Type: ANDA
Sponsor: GLASSHOUSE PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	CREAM;TOPICAL	0.05%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A211207-001	CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL			2021-03-26

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
2026-09-14 22:38:34	2026-08	A211207-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2021-03-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211207-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2021-03-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211207-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2021-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211207-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2021-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211207-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2021-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211207-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2021-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211207-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2021-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211207-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2021-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211207-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2021-03-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211207-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2021-03-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211207-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2021-03-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211207-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2021-03-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211207-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2021-03-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211207-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2021-03-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211207-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2021-03-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211207-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2021-03-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211207-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2021-03-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211207-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2021-03-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211207-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2021-03-26	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211207-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2021-03-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211207-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2021-03-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211207-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2021-03-26	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211207-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2021-03-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211207-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2021-03-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211207-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2021-03-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211207-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2021-03-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211207-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2021-03-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211207-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2021-03-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211207-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2021-03-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211207-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2021-03-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211207-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2021-03-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211207-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2021-03-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211207-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2021-03-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211207-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2021-03-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211207-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2021-03-26	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211207-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL		2021-03-26	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211207-001	AB1	1	`87673890dc5c…`

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 6 of 6 · 107 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	Glenmark Pharmaceuticals Inc., USA	dfc58f73-e892-4fc3-8726-4e8d1546ebd3	2020-09-07	Warnings, Adverse reactions	Name fallback brand name: CLOBETASOL PROPIONATE generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Glenmark Pharmaceuticals Inc., USA	420deed6-321f-4a2a-9042-1e61636621aa	2020-08-26	Adverse reactions	Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Actavis Pharma, Inc.	afd20e23-b7a6-46ca-bd8d-b7af9ff84201	2020-02-29	Warnings, Adverse reactions	Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE
clobetasol propionate	CLOBETASOL PROPIONATE	Lupin Pharmaceuticals,Inc.	3e0fe7b1-f511-491f-b74d-3ca00449835b	2018-08-10	Adverse reactions	Name fallback brand name: clobetasol propionate generic name: CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	Glenmark Pharmaceuticals Inc., USA	e37dd885-889a-4bfd-9813-bb7b9b96cee1	2018-04-18	Adverse reactions	Name fallback brand name: CLOBETASOL PROPIONATE generic name: CLOBETASOL PROPIONATE
clobetasol propionate	CLOBETASOL PROPIONATE	Novel Laboratories, Inc.	c7c03887-f84a-417e-a8f1-5272f530d0bb	2016-05-21	Adverse reactions	Name fallback brand name: clobetasol propionate generic name: CLOBETASOL PROPIONATE
clobetasol propionate	CLOBETASOL PROPIONATE	Novel Laboratories, Inc.	afa1c879-36b9-401e-85d4-638ceec8f444	2016-04-28	Adverse reactions	Name fallback brand name: clobetasol propionate generic name: CLOBETASOL PROPIONATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71428-005	Clobetasol Propionate	Clobetasol Propionate	Glasshouse Pharmaceuticals Limited Canada	ANDA	Current
71428-005	Clobetasol Propionate	Clobetasol Propionate	Glasshouse Pharmaceuticals Limited Canada	ANDA	Current