Application 062776

Type: ANDA
Sponsor: ACP NIMBLE

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 · 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
A062776-001	NYSTATIN	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL			1987-12-17

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A062776-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	1987-12-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062776-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	1987-12-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062776-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	1987-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062776-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	1987-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062776-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	1987-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062776-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	1987-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062776-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	1987-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062776-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	1987-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062776-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	1987-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062776-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	1987-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062776-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	1987-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062776-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	1987-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062776-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	1987-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062776-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	1987-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062776-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	1987-12-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062776-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	1987-12-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062776-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	1987-12-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062776-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	1987-12-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062776-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	1987-12-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062776-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	1987-12-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062776-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	1987-12-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062776-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	1987-12-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062776-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	1987-12-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062776-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	1987-12-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062776-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	1987-12-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062776-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	1987-12-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062776-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	1987-12-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062776-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	1987-12-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062776-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	1987-12-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062776-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	1987-12-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062776-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	1987-12-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062776-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	1987-12-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062776-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	1987-12-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062776-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	1987-12-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062776-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	1987-12-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062776-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	1987-12-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062776-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	1987-12-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062776-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	1987-12-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062776-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	1987-12-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062776-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	1987-12-17	`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 3 of 5 · 88 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NYSTATIN	NYSTATIN	Aurobindo Pharma Limited	7d8a30ab-465e-4804-a06b-afd689e16683	2025-06-18	Adverse reactions	Name fallback brand name: NYSTATIN generic name: NYSTATIN
Nystatin	NYSTATIN	A-S Medication Solutions	a1b5ccb2-d0d6-46cc-b792-6920b50d0a03	2025-05-15	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
Nystatin	NYSTATIN	Bryant Ranch Prepack	72dc2b60-29a4-48a8-848a-1a5086cfdd58	2025-04-03	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
Nystatin	NYSTATIN	Bryant Ranch Prepack	cc8f9a06-cd1b-40e9-bc22-7e19f6d89b83	2025-04-02	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
Nystatin	NYSTATIN	NuCare Pharmaceuticals,Inc.	cf6b7c68-7769-1808-e053-2995a90aa426	2025-02-10	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
Nystatin	NYSTATIN	Padagis Israel Pharmaceuticals Ltd	6c091c66-2e4d-4412-b7bf-35315dc8152f	2025-01-23	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
NYSTATIN	NYSTATIN	DIRECT RX	cd387929-5b72-e3c0-e053-2a95a90adb22	2025-01-20	Adverse reactions	Name fallback brand name: NYSTATIN generic name: NYSTATIN
NYSTATIN	NYSTATIN	NuCare Pharmaceuticals,Inc.	0b4dfd5e-641e-40e9-e063-6294a90a3fda	2025-01-03	Adverse reactions	Name fallback brand name: NYSTATIN generic name: NYSTATIN
NYSTATIN	NYSTATIN	Zydus Lifesciences Limited	5d593aa9-f2e4-4adf-9f02-37832ffcb5b4	2024-12-03		Name fallback brand name: NYSTATIN generic name: NYSTATIN
NYSTATIN	NYSTATIN	Leading Pharma, LLC	954205d8-47ba-4c89-95cd-f0066a514cf9	2024-11-28	Adverse reactions	Name fallback brand name: NYSTATIN generic name: NYSTATIN
Nystatin	NYSTATIN	NuCare Pharmaceuticals,Inc.	6599b544-60bd-ab30-e053-2a91aa0a67b6	2024-11-20	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
Nystatin	NYSTATIN	A-S Medication Solutions	f410ba07-9183-40a8-a2a6-46d3e9761470	2024-11-06	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
Nystop	NYSTATIN	Padagis US LLC	e1b4622c-0f9f-4c00-b42c-2aa85a5e3d4f	2024-10-31	Adverse reactions	Name fallback generic name: NYSTATIN
Nystatin	NYSTATIN	A-S Medication Solutions	65167baa-29f8-44d3-b2d2-935c862d463e	2024-10-16	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
Nystatin	NYSTATIN	Bryant Ranch Prepack	b69d9035-bdf5-4c5a-94d8-f8438f6f0567	2024-08-27	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
Nystatin	NYSTATIN	Zydus Lifesciences Limited	6aa2f67e-9636-45e5-be1b-83e7ab86e436	2024-08-16		Name fallback brand name: Nystatin generic name: NYSTATIN
Nystatin	NYSTATIN	NuCare Pharmaceuticals,Inc.	57825c04-dcb5-b76d-e053-2991aa0a4c1d	2024-08-14	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
Nystatin	NYSTATIN	NuCare Pharmaceuticals,Inc.	86cfb84c-dcd3-b229-e053-2a91aa0aed5c	2024-08-14	Adverse reactions	Name fallback brand name: Nystatin generic name: NYSTATIN
NYSTATIN	NYSTATIN	Leading Pharma, LLC	089e6444-2bd1-443e-acf0-dfeaa69faef9	2024-04-18		Name fallback brand name: NYSTATIN generic name: NYSTATIN
Nystatin	NYSTATIN	Dr. Reddy's Labratories Inc.	6bde84a1-341d-09ce-58b6-f9a653dc98c5	2024-04-12	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.