Application 090219

Type: ANDA
Sponsor: GLENMARK PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLOTRIMAZOLE	CLOTRIMAZOLE	CREAM;TOPICAL	1%	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
A090219-001	CLOTRIMAZOLE	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB		2010-08-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090219-001	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	A090219-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB		2010-08-03	`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	A090219-001	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
Clotrimazole	CLOTRIMAZOLE	Redpharm Drug	53cafc9f-7761-83a9-e063-6294a90a3437	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090219 application number: ANDA090219
Clotrimazole	CLOTRIMAZOLE	Glenmark Pharmaceuticals Inc., USA	f6898117-14f3-42d2-bc0e-d296add3ad70	2026-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090219 application number: ANDA090219 ndc (product): 68462-181
Clotrimazole	CLOTRIMAZOLE	A-S Medication Solutions	116be3a8-9a57-4b4a-a873-98a4ce83bcf7	2025-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090219 application number: ANDA090219

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
68462-181	Clotrimazole	Clotrimazole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current