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 1.

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 1 of 3 · 82 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
2026-02-19 14:30 UTC	2026-02	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`74a2ff9319b5…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2022-03-09 01:35 UTC	2022-03	A080706-006	AT	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A080706-007	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080706-006	AT	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A080706-007	AT	1	`782e0a99824c…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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