Application 210532

Type: ANDA
Sponsor: EPIC PHARMA LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NYSTATIN	NYSTATIN	POWDER;TOPICAL	100,000 UNITS/GM	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
A210532-001	KLAYESTA	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT		2018-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210532-001	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.

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	A210532-001	KLAYESTA	100,000 UNITS/GM	POWDER / TOPICAL	AT		2018-04-30	`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	A210532-001	AT	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
KLAYESTA	NYSTATIN TOPICAL POWDER	Epic Pharma, LLC	0df13b1e-0e07-4123-a83a-1d7afb56170f	2025-12-17	Adverse reactions	Exact identifier application applno (ANDA): 210532 application number: ANDA210532
Nystatin Topical Powder	NYSTATIN TOPICAL POWDER	Epic Pharma, LLC	fb2a480e-0bb1-445e-bbb6-701dea6dc631	2023-08-10	Adverse reactions	Exact identifier application applno (ANDA): 210532 application number: ANDA210532
Nystatin Topical Powder	NYSTATIN TOPICAL POWDER	Epic Pharma, LLC	7f313a3b-7a4c-47fb-ad9f-e267514db527	2018-05-02	Adverse reactions	Exact identifier application applno (ANDA): 210532 application number: ANDA210532 ndc (product): 42806-178

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
42806-178	Nystatin Topical Powder	Nystatin Topical Powder	Epic Pharma, LLC	ANDA	Current