Application 065175

Type: ANDA
Sponsor: XGEN PHARMS

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
A065175-001	NYSTATIN	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL			2004-12-17

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.

Product history page 1 of 2 · 41 observed 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
2026-02-19 14:30 UTC	2026-02	A065175-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL		2004-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065175-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL		2004-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065175-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL		2004-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065175-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2004-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065175-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2004-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065175-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2004-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065175-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2004-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065175-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2004-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065175-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2004-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065175-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2004-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065175-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2004-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065175-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2004-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065175-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2004-12-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065175-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2004-12-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065175-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2004-12-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065175-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2004-12-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065175-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2004-12-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065175-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2004-12-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065175-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2004-12-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065175-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2004-12-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065175-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2004-12-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065175-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2004-12-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065175-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2004-12-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065175-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2004-12-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065175-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2004-12-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065175-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2004-12-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065175-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2004-12-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065175-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2004-12-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065175-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2004-12-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065175-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2004-12-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065175-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2004-12-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065175-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2004-12-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065175-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2004-12-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065175-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2004-12-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065175-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2004-12-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065175-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2004-12-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065175-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2004-12-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065175-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2004-12-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065175-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2004-12-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065175-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2004-12-17	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065175-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065175-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065175-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065175-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065175-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065175-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065175-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065175-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065175-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065175-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065175-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065175-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065175-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065175-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065175-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065175-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065175-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065175-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065175-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065175-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065175-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065175-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065175-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065175-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065175-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065175-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065175-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065175-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065175-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065175-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065175-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065175-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065175-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065175-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065175-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065175-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065175-001	AT	1	`cb3db0bc1861…`

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 1 of 5 · 87 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NYSTATIN	NYSTATIN	Preferred Pharmaceuticals Inc.	8211a0ef-98a8-4136-986c-23c306db1159	2026-08-05	Adverse reactions	Name fallback brand name: NYSTATIN generic name: NYSTATIN
nystatin	NYSTATIN	Preferred Pharmaceuticals Inc.	197e3046-3e58-4246-b260-f3995dce41a1	2026-08-05	Adverse reactions	Name fallback brand name: nystatin generic name: NYSTATIN
Nystatin	NYSTATIN	Preferred Pharmaceuticals Inc.	d92f67a7-dcae-41c0-9a35-dbafa2361170	2026-08-04	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
Nystatin	NYSTATIN	A-S Medication Solutions	98bd8ccb-0c68-47b9-bcb4-c5d8217868d9	2026-07-24	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
Nystatin	NYSTATIN	PAI Holdings, LLC dba PAI Pharma	28b4e26e-206a-4e8a-abfe-774b780e91c3	2026-07-21	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
Nystop	NYSTATIN	Bryant Ranch Prepack	0bb31239-fb77-442a-a9ee-ba61b45e7e68	2026-07-14	Adverse reactions	Name fallback generic name: NYSTATIN
Nystatin	NYSTATIN	Bryant Ranch Prepack	2d2c4f79-95b5-417e-b5c1-8fac1dd09ddc	2026-07-09	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
NYSTATIN	NYSTATIN	Kesin Pharma Corporation	50737729-a4a4-e747-e063-6394a90adcc5	2026-06-30	Adverse reactions	Name fallback brand name: NYSTATIN generic name: NYSTATIN
NYSTATIN	NYSTATIN	Bryant Ranch Prepack	4f6f59fb-ae7d-48e5-b23e-a1d92160974f	2026-05-11	Adverse reactions	Name fallback brand name: NYSTATIN generic name: NYSTATIN
Nystatin	NYSTATIN	Torrent Pharmaceuticals Limited	4949dea7-d2b9-4e0d-974a-39408fa174ba	2026-05-08	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
NYSTATIN	NYSTATIN	Genus Lifesciences Inc.	b25cbae5-eaf5-4501-b013-02c778ca4a4e	2026-05-07	Adverse reactions	Name fallback brand name: NYSTATIN generic name: NYSTATIN
Nystatin	NYSTATIN	Torrent Pharmaceuticals Limited	559b5bd4-3564-4437-8d0a-fa3a972f8b83	2026-05-01	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
Mycostatin	NYSTATIN	Direct_Rx	f1857ac0-806c-4a7e-e053-2995a90abbc0	2026-03-17	Adverse reactions	Name fallback generic name: NYSTATIN
Nystatin	NYSTATIN	A-S Medication Solutions	f1b13a36-c349-4e26-a322-3ec02c610155	2026-03-16	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
Nystatin	NYSTATIN	Chartwell RX, LLC	9954118e-abe6-4388-98c9-4473d39b2e28	2026-03-05	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
Nystatin	NYSTATIN	Cardinal Health 107, LLC	d59098da-1395-49fb-9fd6-947bbbeed56f	2026-02-26	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
Nystatin	NYSTATIN	Major Pharmaceuticals	17b9e33d-da9c-467a-bbc4-9e257727f19a	2026-02-23	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
Nystatin Oral Suspension	NYSTATIN	Xttrium Laboratories, Inc.	4a670371-d373-1ba6-e063-6394a90a13b6	2026-02-06	Adverse reactions	Name fallback generic name: NYSTATIN
Nystatin	NYSTATIN	RedPharm Drug, Inc	f4c298d5-b012-7b56-e053-2a95a90a3d55	2026-01-24	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
NYSTATIN	NYSTATIN	ATLANTIC BIOLOGICALS CORP.	5c08148f-83e5-4f14-b0d3-af8d2c26062e	2026-01-13	Adverse reactions	Name fallback brand name: NYSTATIN generic name: NYSTATIN

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
39822-3015	Nystatin	Nystatin	X-GEN Pharmaceuticals, Inc.	ANDA	Current
39822-3015	Nystatin	Nystatin	X-GEN Pharmaceuticals, Inc.	ANDA	Current
39822-3015	Nystatin	Nystatin	XGen Pharmaceuticals DJB, Inc.	ANDA	Current
42543-052	Nystatin	Nystatin	Vensun Pharmaceuticals, Inc.	ANDA	Current
42543-352	Nystatin	Nystatin	Vensun Pharmaceuticals, Inc.	ANDA	Current
42543-352	Nystatin	Nystatin	Vensun Pharmaceuticals, Inc.	ANDA	Current
42543-352	Nystatin	Nystatin	Vensun Pharmaceuticals, Inc.	ANDA	Current
71205-106	Nystatin	Nystatin	Proficient Rx LP	ANDA	Current
71205-106	Nystatin	Nystatin	Proficient Rx LP	ANDA	Current