Application 208287

Type: ANDA
Sponsor: TELIGENT PHARMA 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 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
A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN; TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL			2016-12-30

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	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL		2016-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL		2016-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL		2016-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL		2016-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL		2016-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL		2016-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL		2016-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL		2016-12-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL		2016-12-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL		2016-12-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL		2016-12-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL		2016-12-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL		2016-12-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL		2016-12-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2016-12-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2016-12-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2016-12-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2016-12-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2016-12-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2016-12-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2016-12-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2016-12-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2016-12-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2016-12-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2016-12-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2016-12-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2016-12-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL		2016-12-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL		2016-12-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL		2016-12-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL		2016-12-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL		2016-12-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2016-12-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2016-12-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2016-12-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2016-12-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2016-12-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2016-12-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2016-12-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2016-12-30	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208287-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208287-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208287-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208287-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208287-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208287-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208287-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208287-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208287-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208287-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208287-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208287-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208287-001	AT	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208287-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208287-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208287-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208287-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208287-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208287-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208287-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208287-001	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 2 · 36 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	Name fallback brand name: Nystatin and triamcinolone acetonide
Nystatin and triamcinolone acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Preferred Pharmaceuticals Inc.	c529567b-7061-4389-8c7a-20ef2b22c591	2026-01-16	Adverse reactions	Name fallback brand name: Nystatin and triamcinolone acetonide
Nystatin and Triamcinolone Acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	REMEDYREPACK INC.	ea065dd4-dfd3-46a2-92de-8a0b49cb9455	2026-01-14	Adverse reactions	Name fallback brand name: Nystatin and Triamcinolone Acetonide
Nystatin and Triamcinolone Acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Crown Laboratories	54aae5d3-e482-4da0-a1b2-0ed70e6c2915	2026-01-12	Adverse reactions	Name fallback brand name: Nystatin and Triamcinolone Acetonide
Nystatin and Triamcinolone Acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Lupin Pharmaceuticals, Inc.	09140e74-c5ea-4c45-a5b1-e6f7f9ee1a23	2025-11-28	Adverse reactions	Name fallback brand name: Nystatin and Triamcinolone Acetonide
NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN, TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	f81f461b-54cd-45bf-bf96-da77a5edc1e6	2025-10-28	Adverse reactions	Name fallback brand name: NYSTATIN AND TRIAMCINOLONE ACETONIDE
Nystatin and Triamcinolone Acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	d36c64f7-5481-45e4-ac9c-e16ae2194c6e	2025-10-22	Adverse reactions	Name fallback brand name: Nystatin and Triamcinolone Acetonide
Nystatin and Triamcinolone Acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	26fd7fb6-6eeb-47f1-bbc4-001e84f99625	2025-10-22	Adverse reactions	Name fallback brand name: Nystatin and Triamcinolone Acetonide
Nystatin and Triamcinolone Acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Encube Ethicals, Inc.	d33829fc-86df-4e28-82c3-9dbcd8a9e28d	2025-08-29	Adverse reactions	Name fallback brand name: Nystatin and Triamcinolone Acetonide
Nystatin and Triamcinolone Acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Preferred Pharmaceuticals Inc., USA	dc886fb9-535c-4fd8-959a-f590a3bf3668	2025-08-28	Adverse reactions	Name fallback brand name: Nystatin and Triamcinolone Acetonide
Nystatin and Triamcinolone Acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Preferred Pharmaceuticals Inc.	4fd65dbf-8e50-4a4a-b06d-e5abab0f3dcd	2025-08-28	Adverse reactions	Name fallback brand name: Nystatin and Triamcinolone Acetonide
Nystatin and Triamcinolone Acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Sun Pharmaceutical Industries, Inc.	2fd97fc5-cae5-43dd-a3c7-c9a03876153e	2025-07-07	Adverse reactions	Name fallback brand name: Nystatin and Triamcinolone Acetonide
NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN, TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	c82fc464-d021-4a7c-8141-46d3d80134a2	2025-05-07	Adverse reactions	Name fallback brand name: NYSTATIN AND TRIAMCINOLONE ACETONIDE
Nystatin and Triamcinolone Acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Alembic Pharmaceuticals Limited	51966a3b-dc09-4f41-941f-0f9247974d88	2025-04-08	Adverse reactions	Name fallback brand name: Nystatin and Triamcinolone Acetonide
Nystatin and Triamcinolone Acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Preferred Pharmaceuticals Inc.	6115a76d-4bad-4829-b2bc-3a077154109d	2025-01-20	Adverse reactions	Name fallback brand name: Nystatin and Triamcinolone Acetonide
Nystatin and Triamcinolone Acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	ec28a12b-96f8-44ff-a440-8cff34ac2095	2024-11-06	Adverse reactions	Name fallback brand name: Nystatin and Triamcinolone Acetonide
NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN, TRIAMCINOLONE ACETONIDE	NuCare Pharmaceuticals,Inc.	c8beaa42-eb3a-d160-e053-2a95a90a3108	2024-10-03	Adverse reactions	Name fallback brand name: NYSTATIN AND TRIAMCINOLONE ACETONIDE
NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN, TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	b3056a63-d149-4ed4-84bc-918f5ff94a62	2024-08-22	Adverse reactions	Name fallback brand name: NYSTATIN AND TRIAMCINOLONE ACETONIDE
Nystatin and Triamcinolone Acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	c62979d3-c9a4-4d94-956e-30760266daf4	2024-08-20	Adverse reactions	Name fallback brand name: Nystatin and Triamcinolone Acetonide
Nystatin and Triamcinolone Acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Zydus Lifesciences Limited	7b878bc9-9a6f-41b8-9d5a-287c01d8cf7f	2024-08-16		Name fallback brand name: Nystatin and Triamcinolone Acetonide

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
52565-042	Nystatin and Triamcinolone Acetonide	Nystatin and Triamcinolone Acetonide	Teligent Pharma, Inc.	ANDA	Current
52565-042	Nystatin and Triamcinolone Acetonide	Nystatin and Triamcinolone Acetonide	Teligent Pharma, Inc.	ANDA	Current