Application 209701

Type: ANDA
Sponsor: XIROMED

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	OINTMENT;TOPICAL	0.05%	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
A209701-001	CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2018-04-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209701-001	AB

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.

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
2026-08-01 22:54:32	2026-06	A209701-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2018-04-17	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A209701-001	AB	1	`a50c72e98297…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clobetasol Propionate	CLOBETASOL PROPIONATE	AvKARE	a862de41-1500-9136-e053-2a95a90a6080	2023-07-03	Adverse reactions	Exact identifier application applno (ANDA): 209701 application number: ANDA209701 ndc (product): 42291-077
Clobetasol Propionate	CLOBETASOL PROPIONATE	A-S Medication Solutions	f8e06ea9-bd18-48db-9f53-8e75734c8f01	2023-03-27	Adverse reactions	Exact identifier application applno (ANDA): 209701 application number: ANDA209701
Clobetasol Propionate	CLOBETASOL PROPIONATE	Xiromed, LLC	56e6d233-d9ee-f022-3be7-d100799a561e	2020-11-06	Adverse reactions	Exact identifier application applno (ANDA): 209701 application number: ANDA209701 ndc (product): 70700-106

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42291-077	Clobetasol Propionate	clobetasol propionate	AvKARE	ANDA	Current
42291-077	Clobetasol Propionate	clobetasol propionate	AvKARE	ANDA	Current
70700-106	Clobetasol Propionate	clobetasol propionate	Xiromed, LLC	ANDA	Current
70700-106	Clobetasol Propionate	clobetasol propionate	Xiromed, LLC	ANDA	Current
70700-106	Clobetasol Propionate	clobetasol propionate	Xiromed, LLC	ANDA	Current
70700-106	Clobetasol Propionate	clobetasol propionate	Xiromed, LLC	ANDA	Current
70700-106	Clobetasol Propionate	clobetasol propionate	Xiromed, LLC	ANDA	Current