Application 214181

Type: ANDA
Sponsor: MACLEODS PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN; TRIAMCINOLONE ACETONIDE	CREAM;TOPICAL	100,000 UNITS/GM;0.1%	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
A214181-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN; TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT		2022-07-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214181-001	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.

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	A214181-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2022-07-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214181-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2022-07-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214181-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2022-07-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214181-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2022-07-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214181-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2022-07-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214181-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2022-07-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214181-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2022-07-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214181-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2022-07-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214181-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2022-07-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214181-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2022-07-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214181-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2022-07-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214181-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2022-07-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214181-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2022-07-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214181-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2022-07-13	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214181-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2022-07-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214181-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2022-07-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214181-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2022-07-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214181-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2022-07-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214181-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2022-07-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214181-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2022-07-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214181-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2022-07-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214181-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2022-07-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214181-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2022-07-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214181-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2022-07-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214181-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2022-07-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214181-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2022-07-13	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214181-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2022-07-13	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A214181-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214181-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214181-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214181-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214181-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214181-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214181-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214181-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214181-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214181-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214181-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214181-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214181-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214181-001	AT	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214181-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214181-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214181-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214181-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214181-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214181-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214181-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214181-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214181-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214181-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214181-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214181-001	AT	1	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214181-001	AT	1	`a50c72e98297…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nystatin and triamcinolone acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	NuCare Pharmaceuticals, Inc.	4c122a83-a66a-15d6-e063-6294a90acfaa	2026-03-02	Adverse reactions	Exact identifier application applno (ANDA): 214181 application number: ANDA214181
Nystatin and triamcinolone acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Preferred Pharmaceuticals Inc.	c529567b-7061-4389-8c7a-20ef2b22c591	2026-01-16	Adverse reactions	Exact identifier application applno (ANDA): 214181 application number: ANDA214181
Nystatin and triamcinolone acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Macleods Pharmaceuticals Limited	57c4ebe8-7a8d-4fc0-b6cf-a276b68327fb	2023-09-07	Adverse reactions	Exact identifier application applno (ANDA): 214181 application number: ANDA214181 ndc (product): 33342-482

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
33342-482	Nystatin and triamcinolone acetonide	Nystatin and triamcinolone acetonide	Macleods Pharmaceuticals Limited	ANDA	Current