Application 061966

Type: ANDA
Sponsor: ACP NIMBLE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NYSTATIN	NYSTATIN	CREAM;TOPICAL	100,000 UNITS/GM	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A061966-001	NYSTATIN	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A061966-001	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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A061966-001	AT	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A061966-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A061966-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A061966-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061966-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A061966-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061966-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061966-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061966-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061966-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061966-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061966-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A061966-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061966-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061966-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A061966-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A061966-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A061966-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A061966-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A061966-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A061966-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A061966-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A061966-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A061966-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A061966-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A061966-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A061966-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A061966-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A061966-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A061966-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A061966-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A061966-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A061966-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A061966-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A061966-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A061966-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A061966-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A061966-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A061966-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A061966-001	AT	1	`3a93d1ddd44b…`

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 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nystatin	NYSTATIN	A-S Medication Solutions	98bd8ccb-0c68-47b9-bcb4-c5d8217868d9	2026-07-24	Adverse reactions	Exact identifier application applno (ANDA): 061966 application number: ANDA061966 ndc (product): 50090-3799
Nystatin	NYSTATIN CREAM	NuCare Pharmaceuticals, Inc.	42f21220-c68a-d748-e063-6394a90a1e2f	2025-11-06	Adverse reactions	Exact identifier application applno (ANDA): 061966 application number: ANDA061966
Nystatin	NYSTATIN	A-S Medication Solutions	a1b5ccb2-d0d6-46cc-b792-6920b50d0a03	2025-05-15	Adverse reactions	Exact identifier application applno (ANDA): 061966 application number: ANDA061966 ndc (product): 50090-3772
Nystatin	NYSTATIN CREAM	Cosette Pharmaceuticals, Inc.	ec1b52af-d38e-eba1-e63c-dba4341d3af2	2022-11-22	Adverse reactions	Exact identifier application applno (ANDA): 061966 application number: ANDA061966 ndc (product): 0713-0678
Nystatin	NYSTATIN CREAM	Proficient Rx LP	b1efcc2c-f71a-463d-9a02-fad7550f31ec	2022-11-01	Adverse reactions	Exact identifier application applno (ANDA): 061966 application number: ANDA061966 ndc (product): 71205-723

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 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0713-0678	Nystatin	Nystatin Cream	G&W Laboratories, Inc.	ANDA	Current
0713-0678	Nystatin	Nystatin Cream	Cosette Pharmaceuticals, Inc.	ANDA	Current
0713-0678	Nystatin	Nystatin Cream	Cosette Pharmaceuticals, Inc.	ANDA	Current
0713-0678	Nystatin	Nystatin Cream	Cosette Pharmaceuticals, Inc.	ANDA	Current
50090-3772	Nystatin	Nystatin	A-S Medication Solutions	ANDA	Current
50090-3772	Nystatin	Nystatin	A-S Medication Solutions	ANDA	Current
50090-3772	Nystatin	Nystatin	A-S Medication Solutions	ANDA	Current
50090-3799	Nystatin	Nystatin	A-S Medication Solutions	ANDA	Current
68071-2483	Nystatin	Nystatin Cream	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2658	Nystatin	Nystatin Cream	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7513	Nystatin	Nystatin Cream	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7513	Nystatin	Nystatin Cream	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7513	Nystatin	Nystatin Cream	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-8234	Nystatin	Nystatin Cream	Preferred Pharmaceuticals, Inc.	ANDA	Current
71205-723	Nystatin	Nystatin Cream	Proficient Rx LP	ANDA	Current
72189-046	NYSTATIN	NYSTATIN	Direct_Rx	ANDA	Current