Application 062840

Type: ANDA
Sponsor: ACTAVIS MID ATLANTIC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NYSTATIN	NYSTATIN	OINTMENT;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
A062840-001	NYSTATIN	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT		1987-11-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062840-001	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	A062840-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT		1987-11-13	`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	A062840-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nystatin	NYSTATIN	Actavis Pharma, Inc.	aee7ce4c-8cc6-4446-a4d7-63bc4773066f	2023-10-30	Adverse reactions	Exact identifier application applno (ANDA): 062840 application number: ANDA062840 ndc (product): 0472-0166
Nystatin	NYSTATIN	Proficient Rx LP	d7d04c02-d07d-4382-8f93-5c0c3e68790c	2022-10-01	Adverse reactions	Exact identifier application applno (ANDA): 062840 application number: ANDA062840 ndc (product): 63187-464

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
0472-0166	Nystatin	Nystatin	Actavis Pharma, Inc.	ANDA	Current
0472-0166	Nystatin	Nystatin	Actavis Pharma, Inc.	ANDA	Current
53217-022	Nystatin	Nystatin	Aidarex Pharmaceuticals LLC	ANDA	Current
63187-464	Nystatin	Nystatin	Proficient Rx LP	ANDA	Current
63187-464	Nystatin	Nystatin	Proficient Rx LP	ANDA	Current
63187-464	Nystatin	Nystatin	Proficient Rx LP	ANDA	Current
63187-464	Nystatin	Nystatin	Proficient Rx LP	ANDA	Current