Application 065422

Type: ANDA
Sponsor: VISTAPHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NYSTATIN	NYSTATIN	SUSPENSION;ORAL	100,000 UNITS/ML	No	No

Source provenance: Browse the complete Orange Book source catalog.

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	Approval date	Source SHA-256
2022-04-08 23:34 UTC	2022-04	A065422-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2011-03-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065422-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2011-03-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065422-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2011-03-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065422-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2011-03-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065422-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2011-03-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065422-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2011-03-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065422-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2011-03-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065422-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2011-03-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065422-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2011-03-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065422-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2011-03-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065422-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2011-03-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065422-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2011-03-07	`ea99ee380514…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-08 23:34 UTC	2022-04	A065422-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065422-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065422-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065422-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065422-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065422-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065422-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065422-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065422-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065422-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065422-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065422-001	AA	1	`ea99ee380514…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 5 of 5 · 88 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nystatin	NYSTATIN	Proficient Rx LP	e7f0e152-233a-492e-a297-7bf2c543c113	2022-05-02	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
Nystatin	NYSTATIN	Pharmaceutical Associates, Inc.	31e3da10-5a7b-4bc5-8a4f-3e786b64c13a	2022-01-13	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
Nystatin	NYSTATIN	Macleods Pharmaceuticals Limited	d8ebb61a-a326-4f0d-a346-c3db045c3fb0	2021-08-25	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
nystatin	NYSTATIN	Proficient Rx LP	04d795f3-aad7-4b79-8ebc-43c500afe39b	2021-08-01	Adverse reactions	Name fallback brand name: nystatin generic name: NYSTATIN
Nystatin	NYSTATIN	Macleods Pharmaceuticals Limited	fe3db8b2-9de4-4f9e-b763-8536a1e4cea8	2021-01-29	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
Nystatin	NYSTATIN OINTMENT	Proficient Rx LP	711950c4-1889-4acd-ab76-9a16176ce1e4	2020-03-01	Adverse reactions	Name fallback brand name: Nystatin
Nystatin	NYSTATIN	Proficient Rx LP	5ef15e1c-66dc-4858-8552-d83e42c3883e	2019-11-01	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
NYSTATIN	NYSTATIN	Leading Pharma, LLC	8900ba02-2c6a-4dd4-b82f-45620c06e255	2019-09-19	Adverse reactions	Name fallback brand name: NYSTATIN generic name: NYSTATIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63629-8519	Nystatin	Nystatin	Bryant Ranch Prepack	ANDA	Current
63629-8519	Nystatin	Nystatin	Bryant Ranch Prepack	ANDA	Current
63629-8521	Nystatin	Nystatin	Bryant Ranch Prepack	ANDA	Current
63629-8521	Nystatin	Nystatin	Bryant Ranch Prepack	ANDA	Current
64950-230	Nystatin	Nystatin	Genus Lifescience Inc.	ANDA	Current
66689-008	Nystatin	Nystatin	VistaPharm, Inc.	ANDA	Current
66689-008	Nystatin	Nystatin	VistaPharm, Inc.	ANDA	Current
66689-008	Nystatin	Nystatin	VistaPharm, Inc.	ANDA	Current
66689-008	Nystatin	Nystatin	VistaPharm, Inc.	ANDA	Current