Application 063305

Type: ANDA
Sponsor: TARO

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	Yes

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
A063305-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN; TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	RS	1993-03-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A063305-001	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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A063305-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	RS	1993-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A063305-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	RS	1993-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A063305-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	RS	1993-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A063305-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	RS	1993-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A063305-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	RS	1993-03-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A063305-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	RS	1993-03-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A063305-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	RS	1993-03-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A063305-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	RS	1993-03-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A063305-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	RS	1993-03-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A063305-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	RS	1993-03-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A063305-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	RS	1993-03-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A063305-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	RS	1993-03-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A063305-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	RS	1993-03-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A063305-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	RS	1993-03-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A063305-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	RS	1993-03-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A063305-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	RS	1993-03-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A063305-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	RS	1993-03-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A063305-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	RS	1993-03-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A063305-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	RS	1993-03-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A063305-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	RS	1993-03-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A063305-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	RS	1993-03-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A063305-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	RS	1993-03-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A063305-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	RS	1993-03-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A063305-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	RS	1993-03-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A063305-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	RS	1993-03-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A063305-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	RS	1993-03-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A063305-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	RS	1993-03-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A063305-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	RS	1993-03-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A063305-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	RS	1993-03-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A063305-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	RS	1993-03-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A063305-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	RS	1993-03-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A063305-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	RS	1993-03-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A063305-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	RS	1993-03-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A063305-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	RS	1993-03-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A063305-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	RS	1993-03-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A063305-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	RS	1993-03-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A063305-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	RS	1993-03-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A063305-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	RS	1993-03-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A063305-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	RS	1993-03-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A063305-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	RS	1993-03-29	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A063305-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A063305-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A063305-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A063305-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A063305-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A063305-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A063305-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A063305-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A063305-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A063305-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A063305-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A063305-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A063305-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A063305-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A063305-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A063305-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A063305-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A063305-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A063305-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A063305-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A063305-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A063305-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A063305-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A063305-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A063305-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A063305-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A063305-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A063305-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A063305-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A063305-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A063305-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A063305-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A063305-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A063305-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A063305-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A063305-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A063305-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A063305-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A063305-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A063305-001	AT	1	`cb3db0bc1861…`

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 · 1 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	Sun Pharmaceutical Industries, Inc.	2fd97fc5-cae5-43dd-a3c7-c9a03876153e	2025-07-07	Adverse reactions	Exact identifier application applno (ANDA): 063305 application number: ANDA063305 ndc (product): 51672-1272

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
51672-1272	Nystatin and Triamcinolone Acetonide	Nystatin and Triamcinolone Acetonide	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-1272	Nystatin and Triamcinolone Acetonide	Nystatin and Triamcinolone Acetonide	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current