Application 207741

Type: ANDA
Sponsor: DR REDDYS

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 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
A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN; TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT		2017-01-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207741-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`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	A207741-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207741-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207741-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207741-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207741-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207741-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207741-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207741-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207741-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207741-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207741-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207741-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207741-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207741-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207741-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207741-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207741-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207741-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207741-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207741-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207741-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207741-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207741-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207741-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207741-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207741-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207741-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207741-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207741-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207741-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207741-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207741-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207741-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207741-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207741-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207741-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207741-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207741-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207741-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207741-001	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 · 7 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	Bryant Ranch Prepack	d36c64f7-5481-45e4-ac9c-e16ae2194c6e	2025-10-22	Adverse reactions	Exact identifier application applno (ANDA): 207741 application number: ANDA207741
Nystatin and Triamcinolone Acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	26fd7fb6-6eeb-47f1-bbc4-001e84f99625	2025-10-22	Adverse reactions	Exact identifier application applno (ANDA): 207741 application number: ANDA207741
Nystatin and Triamcinolone Acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Encube Ethicals, Inc.	d33829fc-86df-4e28-82c3-9dbcd8a9e28d	2025-08-29	Adverse reactions	Exact identifier application applno (ANDA): 207741 application number: ANDA207741 ndc (product): 21922-031
Nystatin and Triamcinolone Acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	ec28a12b-96f8-44ff-a440-8cff34ac2095	2024-11-06	Adverse reactions	Exact identifier application applno (ANDA): 207741 application number: ANDA207741
Nystatin and Triamcinolone Acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	c62979d3-c9a4-4d94-956e-30760266daf4	2024-08-20	Adverse reactions	Exact identifier application applno (ANDA): 207741 application number: ANDA207741 ndc (product): 63629-2495
Nystatin and Triamcinolone Acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	3dab5155-9c86-464b-b41b-1507ff49a694	2024-06-06	Adverse reactions	Exact identifier application applno (ANDA): 207741 application number: ANDA207741 ndc (product): 63629-2496
Nystatin and Triamcinolone Acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	f3e21d77-7ca9-4ca9-97f9-b394f7202aa6	2024-03-14	Adverse reactions	Exact identifier application applno (ANDA): 207741 application number: ANDA207741 ndc (product): 63629-2497

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21922-031	Nystatin and Triamcinolone Acetonide	Nystatin and Triamcinolone Acetonide	Encube Ethicals Private Limited	ANDA	Current
21922-031	Nystatin and Triamcinolone Acetonide	Nystatin and Triamcinolone Acetonide	Encube Ethicals Private Limited	ANDA	Current
63629-2495	Nystatin and Triamcinolone Acetonide	Nystatin and Triamcinolone Acetonide	Bryant Ranch Prepack	ANDA	Current
63629-2495	Nystatin and Triamcinolone Acetonide	Nystatin and Triamcinolone Acetonide	Bryant Ranch Prepack	ANDA	Current
63629-2495	Nystatin and Triamcinolone Acetonide	Nystatin and Triamcinolone Acetonide	Bryant Ranch Prepack	ANDA	Current
63629-2495	Nystatin and Triamcinolone Acetonide	Nystatin and Triamcinolone Acetonide	Bryant Ranch Prepack	ANDA	Current
63629-2496	Nystatin and Triamcinolone Acetonide	Nystatin and Triamcinolone Acetonide	Bryant Ranch Prepack	ANDA	Current
63629-2496	Nystatin and Triamcinolone Acetonide	Nystatin and Triamcinolone Acetonide	Bryant Ranch Prepack	ANDA	Current
63629-2496	Nystatin and Triamcinolone Acetonide	Nystatin and Triamcinolone Acetonide	Bryant Ranch Prepack	ANDA	Current
63629-2496	Nystatin and Triamcinolone Acetonide	Nystatin and Triamcinolone Acetonide	Bryant Ranch Prepack	ANDA	Current
63629-2497	Nystatin and Triamcinolone Acetonide	Nystatin and Triamcinolone Acetonide	Bryant Ranch Prepack	ANDA	Current
63629-2497	Nystatin and Triamcinolone Acetonide	Nystatin and Triamcinolone Acetonide	Bryant Ranch Prepack	ANDA	Current
63629-2497	Nystatin and Triamcinolone Acetonide	Nystatin and Triamcinolone Acetonide	Bryant Ranch Prepack	ANDA	Current
70756-811	Nystatin and Triamcinolone Acetonide	Nystatin and Triamcinolone Acetonide	Lifestar Pharma LLC	ANDA	Current
70756-811	Nystatin and Triamcinolone Acetonide	Nystatin and Triamcinolone Acetonide	Lifestar Pharma LLC	ANDA	Current