Application 083231

Type: ANDA
Sponsor: MARNEL PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALA-SCALP	HYDROCORTISONE	LOTION;TOPICAL	2%	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
A083231-001	ALA-SCALP	HYDROCORTISONE	2%	LOTION / TOPICAL		RLD, Approved before 1982

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	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A083231-001	ALA-SCALP	2%	LOTION / TOPICAL	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083231-001	ALA-SCALP	2%	LOTION / TOPICAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A083231-001	ALA-SCALP	2%	LOTION / TOPICAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083231-001	ALA-SCALP	2%	LOTION / TOPICAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083231-001	ALA-SCALP	2%	LOTION / TOPICAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083231-001	ALA-SCALP	2%	LOTION / TOPICAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083231-001	ALA-SCALP	2%	LOTION / TOPICAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083231-001	ALA-SCALP	2%	LOTION / TOPICAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083231-001	ALA-SCALP	2%	LOTION / TOPICAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A083231-001	ALA-SCALP	2%	LOTION / TOPICAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083231-001	ALA-SCALP	2%	LOTION / TOPICAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083231-001	ALA-SCALP	2%	LOTION / TOPICAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083231-001	ALA-SCALP	2%	LOTION / TOPICAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A083231-001	ALA-SCALP	2%	LOTION / TOPICAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083231-001	ALA-SCALP	2%	LOTION / TOPICAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A083231-001	ALA-SCALP	2%	LOTION / TOPICAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A083231-001	ALA-SCALP	2%	LOTION / TOPICAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A083231-001	ALA-SCALP	2%	LOTION / TOPICAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A083231-001	ALA-SCALP	2%	LOTION / TOPICAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A083231-001	ALA-SCALP	2%	LOTION / TOPICAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083231-001	ALA-SCALP	2%	LOTION / TOPICAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A083231-001	ALA-SCALP	2%	LOTION / TOPICAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A083231-001	ALA-SCALP	2%	LOTION / TOPICAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A083231-001	ALA-SCALP	2%	LOTION / TOPICAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A083231-001	ALA-SCALP	2%	LOTION / TOPICAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A083231-001	ALA-SCALP	2%	LOTION / TOPICAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A083231-001	ALA-SCALP	2%	LOTION / TOPICAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A083231-001	ALA-SCALP	2%	LOTION / TOPICAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A083231-001	ALA-SCALP	2%	LOTION / TOPICAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A083231-001	ALA-SCALP	2%	LOTION / TOPICAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A083231-001	ALA-SCALP	2%	LOTION / TOPICAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A083231-001	ALA-SCALP	2%	LOTION / TOPICAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A083231-001	ALA-SCALP	2%	LOTION / TOPICAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A083231-001	ALA-SCALP	2%	LOTION / TOPICAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A083231-001	ALA-SCALP	2%	LOTION / TOPICAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A083231-001	ALA-SCALP	2%	LOTION / TOPICAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A083231-001	ALA-SCALP	2%	LOTION / TOPICAL	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A083231-001	ALA-SCALP	2%	LOTION / TOPICAL	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A083231-001	ALA-SCALP	2%	LOTION / TOPICAL	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A083231-001	ALA-SCALP	2%	LOTION / TOPICAL	Approved before 1982	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocortisone	HYDROCORTISONE LOTION	Allegis Holdings LLC	1a27d8fa-4025-ed68-e063-6394a90a4f37	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083231 application number: ANDA083231
Ala-Scalp	HYDROCORTISONE	Derm Ventures LLC	61498a40-3b3c-4066-89c8-d99686e2d638	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083231 application number: ANDA083231 ndc (product): 77052-010

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0316-0140	Ala Scalp	Hydrocortisone Acetate	Crown Laboratories	ANDA	Current
0316-0140	Ala Scalp	Hydrocortisone Acetate	Crown Laboratories	ANDA	Current
0316-0140	Ala Scalp	Hydrocortisone Acetate	Crown Laboratories	ANDA	Current
0316-1005	Dermasorb HC Complete Kit	Hydrocortisone Lotion with Shampoo and Body Wash	Crown Laboratories	ANDA	Current
72336-120	Ala-Scalp	Hydrocortisone	Lifsa Drugs LLC	ANDA	Current
77052-010	Ala-Scalp	Hydrocortisone	Derm Ventures LLC	ANDA	Current
77052-010	Ala-Scalp	Hydrocortisone	Derm Ventures LLC	ANDA	Current
77052-010	Ala-Scalp	Hydrocortisone	Derm Ventures LLC	ANDA	Current
77052-010	Ala-Scalp	Hydrocortisone	Derm Ventures LLC	ANDA	Current
77052-010	Ala-Scalp	Hydrocortisone	Derm Ventures LLC	ANDA	Current
77052-010	Ala-Scalp	Hydrocortisone	Derm Ventures LLC	ANDA	Current