Application 080706

Type: ANDA
Sponsor: CROWN LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
006	ALA-CORT	HYDROCORTISONE	CREAM;TOPICAL	1%	No	No
007	ALA-CORT	HYDROCORTISONE	CREAM;TOPICAL	2.5%	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A080706-006	ALA-CORT	HYDROCORTISONE	1%	CREAM / TOPICAL	AT	Approved before 1982
A080706-007	ALA-CORT	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT		2016-01-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A080706-006	AT
A080706-007	AT

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 2 of 3 · 86 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
2022-03-09 01:35 UTC	2022-03	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A080706-006	AT	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A080706-007	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A080706-006	AT	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A080706-007	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A080706-006	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080706-007	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080706-006	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080706-007	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080706-006	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080706-007	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080706-006	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080706-007	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080706-006	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080706-007	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080706-006	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080706-007	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080706-006	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080706-007	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080706-006	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080706-007	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080706-006	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080706-007	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080706-006	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A080706-007	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080706-006	AT	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080706-007	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080706-006	AT	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080706-007	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080706-006	AT	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080706-007	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080706-006	AT	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A080706-007	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080706-006	AT	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080706-007	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080706-006	AT	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A080706-007	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080706-006	AT	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A080706-007	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080706-006	AT	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A080706-007	AT	1	`74a2ff9319b5…`

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	04758c46-0ca4-4852-acdc-1f8553ce2e6e	2026-05-21	Adverse reactions	Exact identifier application applno (ANDA): 080706 application number: ANDA080706
Hydrocortisone	HYDROCORTISONE	Preferred Pharmaceuticals, Inc.	026728d4-846b-4bd4-9183-ae6c4a714138	2026-05-11	Adverse reactions	Exact identifier application applno (ANDA): 080706 application number: ANDA080706 ndc (product): 68788-8302
Hydrocortisone	HYDROCORTISONE	Sportpharm LLC	78f43570-b6fd-42eb-bb9e-580abf79bf0d	2026-04-24	Adverse reactions	Exact identifier application applno (ANDA): 080706 application number: ANDA080706
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	5e95eb82-40cd-411b-9006-c27b65db4b3f	2026-03-25	Adverse reactions	Exact identifier application applno (ANDA): 080706 application number: ANDA080706
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	7f262fa3-4d2a-43f2-a4a7-f49f6034cf50	2026-03-25	Adverse reactions	Exact identifier application applno (ANDA): 080706 application number: ANDA080706 ndc (product): 63629-1951
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	3d17e73a-15f5-4881-baf2-47a0149585fd	2026-03-25	Adverse reactions	Exact identifier application applno (ANDA): 080706 application number: ANDA080706 ndc (product): 63629-1952
Hydrocortisone	HYDROCORTISONE	A-S Medication Solutions	5c4c3e02-5272-4a28-a9c8-1c5fa3ae181c	2026-01-30	Adverse reactions	Exact identifier application applno (ANDA): 080706 application number: ANDA080706 ndc (product): 50090-2452
Hydrocortisone	HYDROCORTISONE	Crown Laboratories	a84830ad-73dc-4a2e-b987-0a1103526535	2026-01-12	Adverse reactions	Exact identifier application applno (ANDA): 080706 application number: ANDA080706 ndc (product): 0316-0193 ndc (product): 0316-0186
Alacort	HYDROCORTISONE	Crown Laboratories	de000081-a245-4f6b-9e7c-e47d84b82338	2026-01-12	Adverse reactions	Exact identifier application applno (ANDA): 080706 application number: ANDA080706 ndc (product): 0316-0126 ndc (product): 0316-0128
Hydrocortisone	HYDROCORTISONE	ANI Pharmaceuticals, Inc.	b2918ac7-14b5-4372-9055-8caf6f4bcf37	2025-12-22	Adverse reactions	Exact identifier application applno (ANDA): 080706 application number: ANDA080706 ndc (product): 62559-430 ndc (product): 62559-431
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	b6808d2d-192c-4d70-a2e8-bf13375c0280	2025-11-05	Adverse reactions	Exact identifier application applno (ANDA): 080706 application number: ANDA080706

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 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0316-0126	Alacort	Hydrocortisone	Crown Laboratories	ANDA	Current
0316-0126	Alacort	Hydrocortisone	Crown Laboratories	ANDA	Current
0316-0126	Alacort	Hydrocortisone	Crown Laboratories	ANDA	Current
0316-0128	Alacort	Hydrocortisone	Crown Laboratories	ANDA	Current
0316-0128	Alacort	Hydrocortisone	Crown Laboratories	ANDA	Current
0316-0128	Alacort	Hydrocortisone	Crown Laboratories	ANDA	Current
0316-0186	Hydrocortisone	Hydrocortisone	Crown Laboratories	ANDA	Current
0316-0186	Hydrocortisone	Hydrocortisone	Crown Laboratories	ANDA	Current
0316-0193	Hydrocortisone	Hydrocortisone	Crown Laboratories	ANDA	Current
0316-0193	Hydrocortisone	Hydrocortisone	Crown Laboratories	ANDA	Current
50090-2452	Hydrocortisone	Hydrocortisone	A-S Medication Solutions	ANDA	Current
50090-2452	Hydrocortisone	Hydrocortisone	A-S Medication Solutions	ANDA	Current
50090-2452	Hydrocortisone	Hydrocortisone	A-S Medication Solutions	ANDA	Current
62559-430	Hydrocortisone	Hydrocortisone	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-431	Hydrocortisone	Hydrocortisone	ANI Pharmaceuticals, Inc.	ANDA	Current
63629-1951	Hydrocortisone	Hydrocortisone	Bryant Ranch Prepack	ANDA	Current
63629-1951	Hydrocortisone	Hydrocortisone	Bryant Ranch Prepack	ANDA	Current
63629-1952	Hydrocortisone	Hydrocortisone	Bryant Ranch Prepack	ANDA	Current
63629-1952	Hydrocortisone	Hydrocortisone	Bryant Ranch Prepack	ANDA	Current
65649-501	Proctocort	HYDROCORTISONE	Salix Pharmaceuticals, Inc	ANDA	Current
65649-501	Proctocort	HYDROCORTISONE	Salix Pharmaceuticals, Inc	ANDA	Current
68071-4582	Hydrocortisone	Hydrocortisone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4582	Hydrocortisone	Hydrocortisone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-8302	Hydrocortisone	Hydrocortisone	Preferred Pharmaceuticals, Inc.	ANDA	Current