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 4 of 5 · 88 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nystatin	NYSTATIN	Bryant Ranch Prepack	93d59122-86f3-489d-9790-1ef6c6aff89d	2024-03-26	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
Nystop	NYSTATIN	Bryant Ranch Prepack	87175864-9877-4e80-b870-907abb8ac289	2024-03-22	Adverse reactions	Name fallback generic name: NYSTATIN
Nystatin	NYSTATIN	Padagis Israel Pharmaceuticals Ltd	e630aa3d-11a6-4300-942a-cbdf2d016f77	2024-03-01	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
Nystatin	NYSTATIN	American Health Packaging	d8c251a6-d4da-4664-bff4-6868541d1178	2024-02-22	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
Nystop	NYSTATIN	Bryant Ranch Prepack	5bce98a3-2964-4edc-b8da-8a46dafadf5e	2024-01-11	Adverse reactions	Name fallback generic name: NYSTATIN
Nystatin	NYSTATIN	Proficient Rx LP	8566c432-741f-4af7-91d7-1b7668ce5e95	2023-12-01	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
Nystatin	NYSTATIN OINTMENT	Cosette Pharmaceuticals, Inc.	8f87de59-33f2-32af-ae17-78bf30fb424d	2023-11-29	Adverse reactions	Name fallback brand name: Nystatin
Nystatin	NYSTATIN	A-S Medication Solutions	6a3bb3da-adf9-46d2-a5ff-f796e7aae7a1	2023-11-24	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
NYSTATIN	NYSTATIN	Zydus Pharmaceuticals USA Inc.	2daf159d-6a12-4b5d-97b3-8069c17e7635	2023-11-04	Adverse reactions	Name fallback brand name: NYSTATIN generic name: NYSTATIN
Nystatin	NYSTATIN	Actavis Pharma, Inc.	aee7ce4c-8cc6-4446-a4d7-63bc4773066f	2023-10-30	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
Nystatin	NYSTATIN	A-S Medication Solutions	cc3516cd-985c-489f-b4a1-8477876c5a97	2023-10-19	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
Nystatin	NYSTATIN	Bryant Ranch Prepack	53d1c23b-9cf2-4941-8701-8a7da1b066cc	2023-03-03	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
Nystatin	NYSTATIN	Bryant Ranch Prepack	84383bc5-1282-43d6-9303-23c8fd8d075f	2023-03-03	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
Nystatin	NYSTATIN	A-S Medication Solutions	e069d495-7f1a-4970-8f4d-aa93d124b3fc	2023-02-04	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
NYSTATIN	NYSTATIN	Bryant Ranch Prepack	b06c65cd-5b65-4bc6-aae9-b9381c6f1948	2023-01-26	Adverse reactions	Name fallback brand name: NYSTATIN generic name: NYSTATIN
Nystatin	NYSTATIN CREAM	Cosette Pharmaceuticals, Inc.	ec1b52af-d38e-eba1-e63c-dba4341d3af2	2022-11-22	Adverse reactions	Name fallback brand name: Nystatin
Nystatin	NYSTATIN CREAM	Proficient Rx LP	b1efcc2c-f71a-463d-9a02-fad7550f31ec	2022-11-01	Adverse reactions	Name fallback brand name: Nystatin
Nystatin	NYSTATIN	Teva Pharmaceuticals USA, Inc.	f03b294d-10cd-4bba-92c8-42ae9b110cd0	2022-11-01	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
Nystatin	NYSTATIN	Viona Pharmaceuticals Inc	e135a7d2-adba-48a2-b3e1-07b778cce9b0	2022-10-08	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
Nystatin	NYSTATIN	Proficient Rx LP	d7d04c02-d07d-4382-8f93-5c0c3e68790c	2022-10-01	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