Application 062124

Type: ANDA
Sponsor: FOUGERA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	NYSTATIN	NYSTATIN	OINTMENT;TOPICAL	100,000 UNITS/GM	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A062124-002	NYSTATIN	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062124-002	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.

Product history page 1 of 2 · 43 observed 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
2026-09-14 22:38:34	2026-08	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A062124-002	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062124-002	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062124-002	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062124-002	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062124-002	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062124-002	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062124-002	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062124-002	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062124-002	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062124-002	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062124-002	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062124-002	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062124-002	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062124-002	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062124-002	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062124-002	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062124-002	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062124-002	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062124-002	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062124-002	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062124-002	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062124-002	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062124-002	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062124-002	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062124-002	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062124-002	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062124-002	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062124-002	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062124-002	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062124-002	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062124-002	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062124-002	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062124-002	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062124-002	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062124-002	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062124-002	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062124-002	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062124-002	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062124-002	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062124-002	AT	1	`f41ea6bd6efb…`

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 2 of 5 · 88 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Nystatin	NYSTATIN	Chartwell RX, LLC	30175930-f5fa-403d-a3ac-3bdbbe723641	2025-12-17	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
NYSTATIN	NYSTATIN	Kesin Pharma Corporation	43817169-bbe8-58ee-e063-6294a90a1250	2025-12-11	Adverse reactions	Name fallback brand name: NYSTATIN generic name: NYSTATIN
Nystatin	NYSTATIN	Chartwell Governmental & Specialty RX, LLC	88a0a22e-8d6b-42aa-b225-2d57fb5b3a97	2025-11-12	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
Nystatin	NYSTATIN CREAM	NuCare Pharmaceuticals, Inc.	42f21220-c68a-d748-e063-6394a90a1e2f	2025-11-06	Adverse reactions	Name fallback brand name: Nystatin
Nystatin	NYSTATIN	Bryant Ranch Prepack	b71356cf-7b6e-4ca0-9571-c80fd0d846cb	2025-10-23	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
Nystatin	NYSTATIN	Cardinal Health 107, LLC	56aca0e2-8691-4701-beba-e2315524709f	2025-10-23	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
Nystop	NYSTATIN	Bryant Ranch Prepack	64041bdf-1207-47f6-93f3-bc4656a7d2ae	2025-10-21	Adverse reactions	Name fallback generic name: NYSTATIN
Nystop	NYSTATIN	Bryant Ranch Prepack	affea013-4f09-4e7d-a696-9f501d379af6	2025-10-21	Adverse reactions	Name fallback generic name: NYSTATIN
Nystatin	NYSTATIN	Bryant Ranch Prepack	b6aa24e6-1acb-4fd3-9ec7-11b1a69c1598	2025-10-08	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
Nystatin	NYSTATIN	Northstar Rx LLC	9e6d0b0d-a68f-46aa-a707-3110ecb931b4	2025-09-30	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
Nystatin	NYSTATIN	Bryant Ranch Prepack	840eebe8-5de2-40c5-acfd-03a98b2e790e	2025-09-23	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
Nystatin	NYSTATIN	AvKARE	8fd35f97-5405-2160-ca0f-35034ecd5a92	2025-09-18	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
NYSTATIN	NYSTATIN	Kanchan Healthcare Inc	90a52c3f-3ef7-4f3b-9fe5-40af408e9f2a	2025-09-12	Adverse reactions	Name fallback brand name: NYSTATIN generic name: NYSTATIN
Nystop	NYSTATIN	Bryant Ranch Prepack	69ebb4dd-f45d-448d-97cd-3f8935493975	2025-08-26	Adverse reactions	Name fallback generic name: NYSTATIN
nystatin	NYSTATIN	Bryant Ranch Prepack	a5711dbe-f71c-435c-91f2-38c357532d18	2025-08-19	Adverse reactions	Name fallback brand name: nystatin generic name: NYSTATIN
Nyamyc	NYSTATIN	Upsher-Smith Laboratories, LLC	01b44f91-9b68-464a-9693-b5d3e793bf3c	2025-07-09	Adverse reactions	Name fallback generic name: NYSTATIN
Nystatin	NYSTATIN	Sun Pharmaceutical Industries, Inc.	4d845b3f-ca26-4c47-b424-b6d783cc10e5	2025-07-03	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
nystatin	NYSTATIN	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	e87b8480-987d-4f82-87bf-cf831d6984a1	2025-06-23	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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0168-0007	Nystatin	nystatin	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	ANDA	Current
42254-284	Nystatin	nystatin	Rebel Distributors Corp	ANDA	Current
50436-1425	Nystatin	nystatin	Unit Dose Services	ANDA	Current