Application 202145

Type: ANDA
Sponsor: GLENMARK GENERICS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROCORTISONE BUTYRATE	HYDROCORTISONE BUTYRATE	CREAM;TOPICAL	0.1%	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
A202145-001	HYDROCORTISONE BUTYRATE	HYDROCORTISONE BUTYRATE	0.1%	CREAM / TOPICAL			2013-09-27

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	A202145-001	HYDROCORTISONE BUTYRATE	0.1%	CREAM / TOPICAL		2013-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202145-001	HYDROCORTISONE BUTYRATE	0.1%	CREAM / TOPICAL		2013-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202145-001	HYDROCORTISONE BUTYRATE	0.1%	CREAM / TOPICAL	AB2	2013-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202145-001	HYDROCORTISONE BUTYRATE	0.1%	CREAM / TOPICAL	AB2	2013-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202145-001	HYDROCORTISONE BUTYRATE	0.1%	CREAM / TOPICAL	AB2	2013-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202145-001	HYDROCORTISONE BUTYRATE	0.1%	CREAM / TOPICAL	AB2	2013-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202145-001	HYDROCORTISONE BUTYRATE	0.1%	CREAM / TOPICAL	AB2	2013-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202145-001	HYDROCORTISONE BUTYRATE	0.1%	CREAM / TOPICAL	AB2	2013-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202145-001	HYDROCORTISONE BUTYRATE	0.1%	CREAM / TOPICAL	AB2	2013-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202145-001	HYDROCORTISONE BUTYRATE	0.1%	CREAM / TOPICAL	AB2	2013-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202145-001	HYDROCORTISONE BUTYRATE	0.1%	CREAM / TOPICAL	AB2	2013-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202145-001	HYDROCORTISONE BUTYRATE	0.1%	CREAM / TOPICAL	AB2	2013-09-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202145-001	HYDROCORTISONE BUTYRATE	0.1%	CREAM / TOPICAL	AB2	2013-09-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202145-001	HYDROCORTISONE BUTYRATE	0.1%	CREAM / TOPICAL	AB2	2013-09-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202145-001	HYDROCORTISONE BUTYRATE	0.1%	CREAM / TOPICAL	AB2	2013-09-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202145-001	HYDROCORTISONE BUTYRATE	0.1%	CREAM / TOPICAL	AB2	2013-09-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202145-001	HYDROCORTISONE BUTYRATE	0.1%	CREAM / TOPICAL	AB2	2013-09-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202145-001	HYDROCORTISONE BUTYRATE	0.1%	CREAM / TOPICAL	AB2	2013-09-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202145-001	HYDROCORTISONE BUTYRATE	0.1%	CREAM / TOPICAL	AB2	2013-09-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202145-001	HYDROCORTISONE BUTYRATE	0.1%	CREAM / TOPICAL	AB2	2013-09-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202145-001	HYDROCORTISONE BUTYRATE	0.1%	CREAM / TOPICAL	AB2	2013-09-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202145-001	HYDROCORTISONE BUTYRATE	0.1%	CREAM / TOPICAL	AB2	2013-09-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202145-001	HYDROCORTISONE BUTYRATE	0.1%	CREAM / TOPICAL	AB2	2013-09-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202145-001	HYDROCORTISONE BUTYRATE	0.1%	CREAM / TOPICAL	AB2	2013-09-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202145-001	HYDROCORTISONE BUTYRATE	0.1%	CREAM / TOPICAL	AB2	2013-09-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202145-001	HYDROCORTISONE BUTYRATE	0.1%	CREAM / TOPICAL	AB2	2013-09-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202145-001	HYDROCORTISONE BUTYRATE	0.1%	CREAM / TOPICAL	AB2	2013-09-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202145-001	HYDROCORTISONE BUTYRATE	0.1%	CREAM / TOPICAL	AB2	2013-09-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202145-001	HYDROCORTISONE BUTYRATE	0.1%	CREAM / TOPICAL	AB2	2013-09-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202145-001	HYDROCORTISONE BUTYRATE	0.1%	CREAM / TOPICAL	AB2	2013-09-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202145-001	HYDROCORTISONE BUTYRATE	0.1%	CREAM / TOPICAL	AB2	2013-09-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202145-001	HYDROCORTISONE BUTYRATE	0.1%	CREAM / TOPICAL	AB2	2013-09-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202145-001	HYDROCORTISONE BUTYRATE	0.1%	CREAM / TOPICAL	AB2	2013-09-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202145-001	HYDROCORTISONE BUTYRATE	0.1%	CREAM / TOPICAL	AB2	2013-09-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202145-001	HYDROCORTISONE BUTYRATE	0.1%	CREAM / TOPICAL	AB2	2013-09-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202145-001	HYDROCORTISONE BUTYRATE	0.1%	CREAM / TOPICAL	AB2	2013-09-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202145-001	HYDROCORTISONE BUTYRATE	0.1%	CREAM / TOPICAL	AB2	2013-09-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202145-001	HYDROCORTISONE BUTYRATE	0.1%	CREAM / TOPICAL	AB2	2013-09-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202145-001	HYDROCORTISONE BUTYRATE	0.1%	CREAM / TOPICAL	AB2	2013-09-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202145-001	HYDROCORTISONE BUTYRATE	0.1%	CREAM / TOPICAL	AB2	2013-09-27	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A202145-001	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202145-001	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202145-001	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202145-001	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202145-001	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202145-001	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202145-001	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202145-001	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202145-001	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202145-001	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202145-001	AB2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202145-001	AB2	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202145-001	AB2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202145-001	AB2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202145-001	AB2	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202145-001	AB2	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202145-001	AB2	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202145-001	AB2	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202145-001	AB2	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202145-001	AB2	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202145-001	AB2	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202145-001	AB2	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202145-001	AB2	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202145-001	AB2	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202145-001	AB2	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202145-001	AB2	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202145-001	AB2	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202145-001	AB2	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202145-001	AB2	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202145-001	AB2	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202145-001	AB2	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202145-001	AB2	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202145-001	AB2	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202145-001	AB2	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202145-001	AB2	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202145-001	AB2	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202145-001	AB2	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202145-001	AB2	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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocortisone Butyrate	HYDROCORTISONE BUTYRATE	Sun Pharmaceutical Industries, Inc.	51176835-598d-4da7-8a00-6bd36f52aa82	2026-07-14	Adverse reactions	Name fallback brand name: Hydrocortisone Butyrate generic name: HYDROCORTISONE BUTYRATE
Evesse	HYDROCORTISONE BUTYRATE	Perfero Pharma, Inc.	988b5524-2947-4862-9d5b-e8b7fec5fd9a	2026-05-14	Warnings, Adverse reactions	Name fallback generic name: HYDROCORTISONE BUTYRATE
Hydrocortisone Butyrate	HYDROCORTISONE BUTYRATE	Bryant Ranch Prepack	ce135638-e551-4bb0-bd2b-f97d381a8c7c	2026-04-23	Warnings, Adverse reactions	Name fallback brand name: Hydrocortisone Butyrate generic name: HYDROCORTISONE BUTYRATE
Hydrocortisone Butyrate	HYDROCORTISONE BUTYRATE	Lupin Pharmaceuticals, Inc.	275f3fcf-1170-4df0-9a8d-1482bda409cb	2025-10-13	Warnings, Adverse reactions	Name fallback brand name: Hydrocortisone Butyrate generic name: HYDROCORTISONE BUTYRATE
Hydrocortisone Butyrate	HYDROCORTISONE BUTYRATE	The J. Molner Company LLC	160c463e-80d2-4bca-8b7f-42279617e309	2025-10-06	Warnings, Adverse reactions	Name fallback brand name: Hydrocortisone Butyrate generic name: HYDROCORTISONE BUTYRATE
Hydrocortisone Butyrate	HYDROCORTISONE BUTYRATE	Oceanside Pharmaceuticals	ddf699f4-1ae0-48c3-8d2a-56aa1a2c5bc1	2025-06-05	Warnings, Adverse reactions	Name fallback brand name: Hydrocortisone Butyrate generic name: HYDROCORTISONE BUTYRATE
Hydrocortisone Butyrate	HYDROCORTISONE BUTYRATE	Oceanside Pharmaceuticals	7c3f8417-7861-41e3-876f-9b82aff7d1a0	2020-12-31	Adverse reactions	Name fallback brand name: Hydrocortisone Butyrate generic name: HYDROCORTISONE BUTYRATE

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68462-464	Hydrocortisone Butyrate	Hydrocortisone Butyrate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
19070	ORIG	2013-10-02
9973	ORIG	2013-10-01