Application 085980

Type: ANDA
Sponsor: SEBELA IRELAND LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PRAMOSONE	HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE	LOTION;TOPICAL	1%;1%	No	No

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
A085980-001	PRAMOSONE	HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE	1%;1%	LOTION / TOPICAL		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 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A085980-001	PRAMOSONE	1%;1%	LOTION / TOPICAL	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A085980-001	PRAMOSONE	1%;1%	LOTION / TOPICAL	Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A085980-001	PRAMOSONE	1%;1%	LOTION / TOPICAL	Approved before 1982	`a50c72e98297…`

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
Pramosone	HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE	Sebela Pharmaceuticals Inc.	f207bdff-2f41-4eee-818e-198b6462863e	2025-11-08	Adverse reactions	Exact identifier application applno (ANDA): 085980 application number: ANDA085980 ndc (product): 54766-729
Pramosone	HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE	Legacy Pharma USA Inc.	ce3dd32c-1262-454e-aacb-880d54596dd3	2025-06-09	Adverse reactions	Exact identifier application applno (ANDA): 085980 application number: ANDA085980

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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
54766-729	Pramosone	hydrocortisone acetate and pramoxine hydrochloride	Sebela Pharmaceuticals Inc.	ANDA	Current