Application 062602

Type: ANDA
Sponsor: FOUGERA PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN; TRIAMCINOLONE ACETONIDE	OINTMENT;TOPICAL	100,000 UNITS/GM;0.1%	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
A062602-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN; TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT		1985-10-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062602-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A062602-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	1985-10-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062602-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	1985-10-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062602-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	1985-10-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062602-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	1985-10-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062602-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	1985-10-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062602-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	1985-10-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062602-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	1985-10-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062602-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	1985-10-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062602-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	1985-10-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062602-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	1985-10-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062602-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	1985-10-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062602-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	1985-10-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062602-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	1985-10-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062602-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	1985-10-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062602-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	1985-10-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062602-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	1985-10-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062602-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	1985-10-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062602-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	1985-10-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062602-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	1985-10-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062602-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	1985-10-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062602-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	1985-10-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062602-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	1985-10-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062602-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	1985-10-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062602-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	1985-10-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062602-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	1985-10-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062602-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	1985-10-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062602-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	1985-10-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062602-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	1985-10-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062602-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	1985-10-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062602-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	1985-10-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062602-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	1985-10-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062602-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	1985-10-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062602-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	1985-10-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062602-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	1985-10-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062602-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	1985-10-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062602-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	1985-10-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062602-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	1985-10-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062602-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	1985-10-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062602-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	1985-10-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062602-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	1985-10-09	`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	A062602-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062602-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062602-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062602-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062602-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062602-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062602-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062602-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062602-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062602-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062602-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062602-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062602-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062602-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062602-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062602-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062602-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062602-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062602-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062602-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062602-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062602-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062602-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062602-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062602-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062602-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062602-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062602-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062602-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062602-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062602-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062602-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062602-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062602-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062602-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062602-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062602-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062602-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062602-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062602-001	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 2 · 35 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.	90a58c0e-85cf-3aad-e053-2a95a90a316a	2024-06-19	Adverse reactions	Name fallback brand name: Nystatin and Triamcinolone Acetonide
nystatin and triamcinolone acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	11ee6692-8b04-441b-a981-3a0c9352cbd1	2024-06-18	Adverse reactions	Name fallback brand name: nystatin and triamcinolone acetonide
Nystatin and Triamcinolone Acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	3dab5155-9c86-464b-b41b-1507ff49a694	2024-06-06	Adverse reactions	Name fallback brand name: Nystatin and Triamcinolone Acetonide
NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN, TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	6f25f129-a682-47d0-8788-bac21b65c830	2024-03-29	Adverse reactions	Name fallback brand name: NYSTATIN AND TRIAMCINOLONE ACETONIDE
Nystatin and Triamcinolone Acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	f3e21d77-7ca9-4ca9-97f9-b394f7202aa6	2024-03-14	Adverse reactions	Name fallback brand name: Nystatin and Triamcinolone Acetonide
Nystatin and Triamcinolone Acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Alembic Pharmaceuticals Inc.	1034d417-493a-443a-a62e-30786f673ee3	2023-12-12	Adverse reactions	Name fallback brand name: Nystatin and Triamcinolone Acetonide
Nystatin and Triamcinolone Acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Alembic Pharmaceuticals Inc.	91546bba-d141-4a3b-a4e7-15de2282e7e5	2023-12-12	Adverse reactions	Name fallback brand name: Nystatin and Triamcinolone Acetonide
Nystatin and Triamcinolone Acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Torrent Pharmaceuticals Limited	b20217ad-8c25-471a-9f16-9e681b90db05	2023-09-14	Adverse reactions	Name fallback brand name: Nystatin and Triamcinolone Acetonide
Nystatin and triamcinolone acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Macleods Pharmaceuticals Limited	57c4ebe8-7a8d-4fc0-b6cf-a276b68327fb	2023-09-07	Adverse reactions	Name fallback brand name: Nystatin and triamcinolone acetonide
NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN, TRIAMCINOLONE ACETONIDE	Padagis Israel Pharmaceuticals Ltd	92fc188d-4f3e-4d18-aaf1-c9e76b12b75b	2023-03-01	Adverse reactions	Name fallback brand name: NYSTATIN AND TRIAMCINOLONE ACETONIDE
nystatin and triamcinolone acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Padagis Israel Pharmaceuticals Ltd	605540d8-7189-49b9-9e91-572f6b519fae	2023-03-01	Adverse reactions	Name fallback brand name: nystatin and triamcinolone acetonide
Nystatin and Triamcinolone Acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Viona Pharmaceuticals Inc	d3799da3-5923-4225-9c61-2b5af143f555	2022-10-08	Adverse reactions	Name fallback brand name: Nystatin and Triamcinolone Acetonide
Nystatin and triamcinolone acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Macleods Pharmaceuticals Limited	15bf2ff1-510e-4f0e-9817-8af28790e01b	2021-09-01	Adverse reactions	Name fallback brand name: Nystatin and triamcinolone acetonide
Nystatin and Triamcinolone Acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Glenmark Pharmaceuticals Inc., USA	44a37f35-e533-4b09-bbcf-97ffaff1920b	2021-01-31	Adverse reactions	Name fallback brand name: Nystatin and Triamcinolone Acetonide
Nystatin and Triamcinolone Acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Glenmark Pharmaceuticals Inc., USA	aee696ad-9b16-42db-a6ac-49932efb9fa5	2020-09-21	Adverse reactions	Name fallback brand name: Nystatin and Triamcinolone Acetonide

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0168-0089	Nystatin and Triamcinolone Acetonide	nystatin and triamcinolone acetonide	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	ANDA	Current
0168-0089	Nystatin and Triamcinolone Acetonide	nystatin and triamcinolone acetonide	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	ANDA	Current