Application 062506

Type: ANDA
Sponsor: TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NYSTATIN	NYSTATIN	TABLET;ORAL	500,000 UNITS	No	Yes

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
A062506-001	NYSTATIN	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062506-001	AA

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	A062506-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16	`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	A062506-001	AA	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nystatin	NYSTATIN	AvKARE	8fd35f97-5405-2160-ca0f-35034ecd5a92	2025-09-18	Adverse reactions	Exact identifier application applno (ANDA): 062506 application number: ANDA062506 ndc (product): 42291-651
Nystatin	NYSTATIN	Teva Pharmaceuticals USA, Inc.	f03b294d-10cd-4bba-92c8-42ae9b110cd0	2022-11-01	Adverse reactions	Exact identifier application applno (ANDA): 062506 application number: ANDA062506 ndc (product): 0093-0983

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
0093-0983	Nystatin	Nystatin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0983	Nystatin	Nystatin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0983	Nystatin	Nystatin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0983	Nystatin	Nystatin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
42291-651	Nystatin	Nystatin	AvKARE, Inc.	ANDA	Current
42291-651	Nystatin	Nystatin	AvKARE	ANDA	Current
68151-1487	Nystatin	Nystatin	Carilion Materials Management	ANDA	Current