Application 012104

Type: NDA
Sponsor: SUN PHARM INDS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KENALOG	TRIAMCINOLONE ACETONIDE	SPRAY;TOPICAL	0.147MG/GM	Yes	Yes

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
N012104-001	KENALOG	TRIAMCINOLONE ACETONIDE	0.147MG/GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY / TOPICAL		RLD, Approved before 1982

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	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N012104-001	KENALOG	0.147MG/GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY / TOPICAL		RLD, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N012104-001	KENALOG	0.147MG/GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY / TOPICAL		RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N012104-001	KENALOG	0.147MG/GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY / TOPICAL		RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012104-001	KENALOG	0.147MG/GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY / TOPICAL		RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N012104-001	KENALOG	0.147MG/GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY / TOPICAL		RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012104-001	KENALOG	0.147MG/GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY / TOPICAL		RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012104-001	KENALOG	0.147MG/GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY / TOPICAL		RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012104-001	KENALOG	0.147MG/GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY / TOPICAL		RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012104-001	KENALOG	0.147MG/GM	SPRAY / TOPICAL		RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012104-001	KENALOG	0.147MG/GM	SPRAY / TOPICAL		RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012104-001	KENALOG	0.147MG/GM	SPRAY / TOPICAL		RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N012104-001	KENALOG	0.147MG/GM	SPRAY / TOPICAL		RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012104-001	KENALOG	0.147MG/GM	SPRAY / TOPICAL		RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012104-001	KENALOG	0.147MG/GM	SPRAY / TOPICAL		RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012104-001	KENALOG	0.147MG/GM	SPRAY / TOPICAL		RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N012104-001	KENALOG	0.147MG/GM	SPRAY / TOPICAL		RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012104-001	KENALOG	0.147MG/GM	SPRAY / TOPICAL	AT	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N012104-001	KENALOG	0.147MG/GM	SPRAY / TOPICAL	AT	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N012104-001	KENALOG	0.147MG/GM	SPRAY / TOPICAL	AT	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N012104-001	KENALOG	0.147MG/GM	SPRAY / TOPICAL	AT	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N012104-001	KENALOG	0.147MG/GM	SPRAY / TOPICAL	AT	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N012104-001	KENALOG	0.147MG/GM	SPRAY / TOPICAL	AT	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N012104-001	KENALOG	0.147MG/GM	SPRAY / TOPICAL	AT	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N012104-001	KENALOG	0.147MG/GM	SPRAY / TOPICAL	AT	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N012104-001	KENALOG	0.147MG/GM	SPRAY / TOPICAL	AT	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N012104-001	KENALOG	0.147MG/GM	SPRAY / TOPICAL	AT	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N012104-001	KENALOG	0.147MG/GM	SPRAY / TOPICAL	AT	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N012104-001	KENALOG	0.147MG/GM	SPRAY / TOPICAL	AT	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N012104-001	KENALOG	0.147MG/GM	SPRAY / TOPICAL	AT	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N012104-001	KENALOG	0.147MG/GM	SPRAY / TOPICAL		RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N012104-001	KENALOG	0.147MG/GM	SPRAY / TOPICAL		RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N012104-001	KENALOG	0.147MG/GM	SPRAY / TOPICAL		RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N012104-001	KENALOG	0.147MG/GM	SPRAY / TOPICAL		RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N012104-001	KENALOG	0.147MG/GM	SPRAY / TOPICAL		RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N012104-001	KENALOG	0.147MG/GM	SPRAY / TOPICAL		RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N012104-001	KENALOG	0.147MG/GM	SPRAY / TOPICAL	AT	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N012104-001	KENALOG	0.147MG/GM	SPRAY / TOPICAL	AT	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N012104-001	KENALOG	0.147MG/GM	SPRAY / TOPICAL	AT	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N012104-001	KENALOG	0.147MG/GM	SPRAY / TOPICAL	AT	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N012104-001	KENALOG	0.147MG/GM	SPRAY / TOPICAL	AT	RLD, RS, Approved before 1982	`f41ea6bd6efb…`

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	N012104-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N012104-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N012104-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N012104-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N012104-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N012104-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N012104-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N012104-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N012104-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N012104-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N012104-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N012104-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N012104-001	AT	1	`ea99ee380514…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N012104-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N012104-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N012104-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N012104-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N012104-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N012104-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N012104-001	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 3 of 11 · 208 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	6658728a-99d7-48c3-83d6-4e40c59c9b47	2026-04-07	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Allergy Nasal	TRIAMCINOLONE ACETONIDE	Walgreen Company	a33aa2f3-9e9e-4408-b671-508c79a29c06	2026-04-07	Warnings	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	NuCare Pharmceuticals,Inc.	4e94fde1-ea31-e333-e063-6294a90a5107	2026-04-03	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	10cf5e2f-0e9f-4fc0-af4a-3be46a4af475	2026-04-02	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Sportpharm LLC	8d11aee3-b66e-439b-9188-7d91219a59cf	2026-04-01	Warnings, Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
TRIESENCE	TRIAMCINOLONE ACETONIDE	Novartis Pharmaceuticals Corporation	22692d92-1359-9252-e063-6394a90ab669	2026-04-01	Warnings, Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Direct_rx	4e400049-c763-56f7-e063-6294a90a6fd7	2026-03-30	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	0844a8f0-116d-40f6-8462-cccd6bcefc8a	2026-03-27	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	DIRECTRX	835bbcd1-3869-646c-e053-2a91aa0a796a	2026-03-17	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Direct_rx	20ac5621-cd18-a7dd-e063-6394a90a99fa	2026-03-17	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Asclemed USA, Inc.	b20c22b2-9a74-4b71-9015-40838fd2d193	2026-03-10	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	Direct_Rx	93de78fb-1f19-cfc6-e053-2995a90a9bc7	2026-03-05	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	NuCare Pharmaceuticals,Inc.	bd45c7d2-a1a3-e0f5-e053-2a95a90ae4b3	2026-02-19	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	NuCare Pharmaceuticals,Inc.	bd465674-3527-1590-e053-2995a90a958d	2026-02-19	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	96f18791-480d-49f2-aac6-387321ae552c	2026-02-14	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Amneal Pharmaceuticals LLC	c38dcd37-9840-4f71-a5c9-97380c8107f2	2026-02-12	Warnings, Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	51fedf94-d94e-42b7-8e9f-e0e9b6bbd055	2026-02-11	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Sportpharm LLC	4e0ddecf-7ea1-4f42-9924-53fe5a5657ff	2026-02-10	Warnings, Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	ASCLEMED USA INC.	1c6a740e-bc0d-41f3-b576-7d4c3880be23	2026-02-10	Warnings, Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	REMEDYREPACK INC.	c76d68dc-78e6-407c-ba9d-5d1c5d13509e	2026-02-05	Adverse reactions	Name fallback generic name: 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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10631-093	Kenalog	Triamcinolone Acetonide	Sun Pharmaceutical Industries, Inc.	NDA	Current
71800-156	Triamcinolone Acetonide	Triamcinolone Acetonide	Innovida Pharmaceutique Corporation	NDA	Current
71800-156	Triamcinolone Acetonide	Triamcinolone Acetonide	Innovida Pharmaceutique Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
304	SUPPL	2011-08-03
33074	SUPPL	2011-08-01