Application 208479

Type: ANDA
Sponsor: PERRIGO UK FINCO

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 42.

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
A208479-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN; TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT		2017-08-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208479-001	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 1 of 2 · 42 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
2026-08-18 06:07:40	2026-07	A208479-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2017-08-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208479-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2017-08-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208479-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2017-08-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208479-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2017-08-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208479-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2017-08-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208479-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2017-08-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208479-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2017-08-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208479-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2017-08-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208479-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2017-08-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208479-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2017-08-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208479-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2017-08-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208479-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2017-08-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208479-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2017-08-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208479-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2017-08-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208479-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2017-08-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208479-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2017-08-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208479-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2017-08-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208479-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2017-08-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208479-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2017-08-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208479-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2017-08-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208479-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2017-08-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208479-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2017-08-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208479-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2017-08-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208479-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2017-08-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208479-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2017-08-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208479-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2017-08-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208479-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2017-08-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208479-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2017-08-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208479-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2017-08-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208479-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2017-08-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208479-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2017-08-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208479-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2017-08-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208479-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2017-08-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208479-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2017-08-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208479-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2017-08-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208479-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2017-08-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208479-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2017-08-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208479-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2017-08-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208479-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2017-08-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208479-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	2017-08-14	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A208479-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208479-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208479-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208479-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208479-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208479-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208479-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208479-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208479-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208479-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208479-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208479-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208479-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208479-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208479-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208479-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208479-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208479-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208479-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208479-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208479-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208479-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208479-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208479-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208479-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208479-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208479-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208479-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208479-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208479-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208479-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208479-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208479-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208479-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208479-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208479-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208479-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208479-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208479-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208479-001	AT	1	`e64feba35796…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN, TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	f81f461b-54cd-45bf-bf96-da77a5edc1e6	2025-10-28	Adverse reactions	Exact identifier application applno (ANDA): 208479 application number: ANDA208479
NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN, TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	c82fc464-d021-4a7c-8141-46d3d80134a2	2025-05-07	Adverse reactions	Exact identifier application applno (ANDA): 208479 application number: ANDA208479
NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN, TRIAMCINOLONE ACETONIDE	NuCare Pharmaceuticals,Inc.	c8beaa42-eb3a-d160-e053-2a95a90a3108	2024-10-03	Adverse reactions	Exact identifier application applno (ANDA): 208479 application number: ANDA208479 ndc (product): 68071-2491
NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN, TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	b3056a63-d149-4ed4-84bc-918f5ff94a62	2024-08-22	Adverse reactions	Exact identifier application applno (ANDA): 208479 application number: ANDA208479 ndc (product): 63629-8689
NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN, TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	92b08b14-a933-454b-8b6f-4b5e7c682953	2024-08-06	Adverse reactions	Exact identifier application applno (ANDA): 208479 application number: ANDA208479 ndc (product): 63629-8688
NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN, TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	6f25f129-a682-47d0-8788-bac21b65c830	2024-03-29	Adverse reactions	Exact identifier application applno (ANDA): 208479 application number: ANDA208479 ndc (product): 63629-8690
NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN, TRIAMCINOLONE ACETONIDE	Padagis Israel Pharmaceuticals Ltd	92fc188d-4f3e-4d18-aaf1-c9e76b12b75b	2023-03-01	Adverse reactions	Exact identifier application applno (ANDA): 208479 application number: ANDA208479 ndc (product): 45802-880

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
45802-880	NYSTATIN AND TRIAMCINOLONE ACETONIDE	nystatin, triamcinolone acetonide	Perrigo New York Inc	ANDA	Current
45802-880	NYSTATIN AND TRIAMCINOLONE ACETONIDE	nystatin, triamcinolone acetonide	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
63629-8688	NYSTATIN AND TRIAMCINOLONE ACETONIDE	nystatin, triamcinolone acetonide	Bryant Ranch Prepack	ANDA	Current
63629-8688	NYSTATIN AND TRIAMCINOLONE ACETONIDE	nystatin, triamcinolone acetonide	Bryant Ranch Prepack	ANDA	Current
63629-8688	NYSTATIN AND TRIAMCINOLONE ACETONIDE	nystatin, triamcinolone acetonide	Bryant Ranch Prepack	ANDA	Current
63629-8689	NYSTATIN AND TRIAMCINOLONE ACETONIDE	nystatin, triamcinolone acetonide	Bryant Ranch Prepack	ANDA	Current
63629-8689	NYSTATIN AND TRIAMCINOLONE ACETONIDE	nystatin, triamcinolone acetonide	Bryant Ranch Prepack	ANDA	Current
63629-8689	NYSTATIN AND TRIAMCINOLONE ACETONIDE	nystatin, triamcinolone acetonide	Bryant Ranch Prepack	ANDA	Current
63629-8690	NYSTATIN AND TRIAMCINOLONE ACETONIDE	nystatin, triamcinolone acetonide	Bryant Ranch Prepack	ANDA	Current
63629-8690	NYSTATIN AND TRIAMCINOLONE ACETONIDE	nystatin, triamcinolone acetonide	Bryant Ranch Prepack	ANDA	Current
63629-8690	NYSTATIN AND TRIAMCINOLONE ACETONIDE	nystatin, triamcinolone acetonide	Bryant Ranch Prepack	ANDA	Current
68071-2478	NYSTATIN AND TRIAMCINOLONE ACETONIDE	nystatin, triamcinolone acetonide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2491	NYSTATIN AND TRIAMCINOLONE ACETONIDE	nystatin, triamcinolone acetonide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-8156	NYSTATIN AND TRIAMCINOLONE ACETONIDE	nystatin, triamcinolone acetonide	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-2777	NYSTATIN AND TRIAMCINOLONE ACETONIDE	nystatin, triamcinolone acetonide	REMEDYREPACK INC.	ANDA	Current
70518-2777	NYSTATIN AND TRIAMCINOLONE ACETONIDE	nystatin, triamcinolone acetonide	REMEDYREPACK INC.	ANDA	Current