Application 021535

Type: NDA
Sponsor: GALDERMA LABS LP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLOBEX	CLOBETASOL PROPIONATE	LOTION;TOPICAL	0.05%	Yes	Yes

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
N021535-001	CLOBEX	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021535-001	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 · 43 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
2026-09-14 22:38:34	2026-08	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N021535-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021535-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021535-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021535-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021535-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021535-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021535-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021535-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021535-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021535-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021535-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021535-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021535-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021535-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021535-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021535-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021535-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021535-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021535-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021535-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021535-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021535-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021535-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021535-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021535-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021535-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021535-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021535-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021535-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021535-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021535-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021535-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021535-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021535-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021535-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021535-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021535-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021535-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021535-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021535-001	AB	1	`f41ea6bd6efb…`

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 4 of 5 · 95 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	Aurobindo Pharma Limited	e238bf90-f5fd-446d-9799-e8f8fed2f0a9	2024-02-28	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Impoyz	CLOBETASOL PROPIONATE	Primus Pharmaceuticals, Inc.	40173654-334e-4618-847b-6a1e030cd2fd	2024-01-30	Warnings, Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
clobetasol propionate	CLOBETASOL PROPIONATE	Lupin Pharmaceuticals,Inc.	c6efb5f3-3532-4742-a359-3991bb76338f	2024-01-29	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	a178bb79-c0dc-4561-93df-8f7bd9d57bae	2024-01-12	Warnings, Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	Quagen Pharmaceuticals LLC	5f6d2a57-92c9-4568-83d1-524de42182b4	2024-01-10	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate ANDA	CLOBETASOL PROPIONATE	Macleods Pharmaceuticals Limited	92cf4231-e301-4353-98d9-85206ec6ba96	2024-01-05	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	A-S Medication Solutions	846f1ae1-0a7f-4609-b1a0-c749ffc79ce8	2024-01-02	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	Alembic Pharmaceuticals Inc.	a75cac17-c0d1-403a-8a63-80b2d43e3169	2023-12-12	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	Alembic Pharmaceuticals Inc.	0d5ca826-d200-42d8-b9c7-d05ecabb6ab2	2023-12-08	Warnings, Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Cosette Pharmaceuticals, Inc.	807d6a1a-4eca-9cf4-f514-bb1cd7b10d0f	2023-11-28	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clodan	CLOBETASOL PROPIONATE	Medimetriks Pharmaceuticals	b5d32546-65dc-4b0c-826e-ddbc2a50b152	2023-11-20	Warnings, Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	A-S Medication Solutions	e223598e-3cf8-4362-b963-a23ea05072ba	2023-10-16	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
clobetasol propionate	CLOBETASOL PROPIONATE	Mayne Pharma Inc.	524397b3-84c4-49d7-af5e-bb229dfee68b	2023-08-16	Warnings, Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	A-S Medication Solutions	52bf5318-2487-4c7b-aa8d-e98f22cc6104	2023-07-27	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	A-S Medication Solutions	ecef6314-97c0-4f2e-bbcb-53a62ac7fb72	2023-07-27	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	bc021c6c-43db-469c-b1c3-0166b18daea4	2023-07-17	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	695b2b8a-9d8c-4e94-bc78-2f535b8e2cbc	2023-07-17	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	AvKARE	a862de41-1500-9136-e053-2a95a90a6080	2023-07-03	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	A-S Medication Solutions	f8e06ea9-bd18-48db-9f53-8e75734c8f01	2023-03-27	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Padagis Israel Pharmaceuticals Ltd	f9df643a-015d-4101-ac8f-c1e05b052df5	2023-03-01	Adverse reactions	Name fallback 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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0299-3848	Clobex	Clobetasol Propionate	Galderma Laboratories, L.P.	NDA	Current
0574-2103	Clobetasol Propionate	Clobetasol Propionate	Paddock Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
0574-2103	Clobetasol Propionate	Clobetasol Propionate	Paddock Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
0574-2103	Clobetasol Propionate	Clobetasol Propionate	Paddock Laboratories, LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
15712	SUPPL	2014-01-14
5668	SUPPL	2012-12-03
28048	SUPPL	2012-08-20
15711	SUPPL	2012-08-20
21721	ORIG	2004-06-14
28047	ORIG	2003-07-28
15710	ORIG	2003-07-28