Application 084343

Type: ANDA
Sponsor: DELCOR ASSET CORP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KENALOG	TRIAMCINOLONE ACETONIDE	LOTION;TOPICAL	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
002	KENALOG	TRIAMCINOLONE ACETONIDE	LOTION;TOPICAL	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A084343-001	KENALOG	TRIAMCINOLONE ACETONIDE	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		Approved before 1982
A084343-002	KENALOG	TRIAMCINOLONE ACETONIDE	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		Approved before 1982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 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-10-15 13:18:30	2026-09	A084343-001	KENALOG	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	Approved before 1982	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A084343-002	KENALOG	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	Approved before 1982	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A084343-001	KENALOG	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A084343-002	KENALOG	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A084343-001	KENALOG	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A084343-002	KENALOG	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A084343-001	KENALOG	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084343-002	KENALOG	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084343-001	KENALOG	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084343-002	KENALOG	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084343-001	KENALOG	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084343-002	KENALOG	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084343-001	KENALOG	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084343-002	KENALOG	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084343-001	KENALOG	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084343-002	KENALOG	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084343-001	KENALOG	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084343-002	KENALOG	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084343-001	KENALOG	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084343-002	KENALOG	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084343-001	KENALOG	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084343-002	KENALOG	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084343-001	KENALOG	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084343-002	KENALOG	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084343-001	KENALOG	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A084343-002	KENALOG	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084343-001	KENALOG	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084343-002	KENALOG	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084343-001	KENALOG	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084343-002	KENALOG	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084343-001	KENALOG	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084343-002	KENALOG	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084343-001	KENALOG	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A084343-002	KENALOG	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084343-001	KENALOG	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084343-002	KENALOG	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084343-001	KENALOG	0.025%	LOTION / TOPICAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A084343-002	KENALOG	0.1%	LOTION / TOPICAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084343-001	KENALOG	0.025%	LOTION / TOPICAL	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A084343-002	KENALOG	0.1%	LOTION / TOPICAL	Approved before 1982	`4b0b4de00fa7…`

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 6 of 10 · 199 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Rising Pharma Holdings, Inc.	15ab1090-47d1-4925-8362-d7dda6fe74a9	2025-04-11	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	NorthStar RxLLC	3379f247-4a29-4373-9843-0b7f044c2276	2025-04-03	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Preferred Pharmaceuticals Inc.	da5652f8-585c-4697-bc65-2a613cb0ef0f	2025-03-20	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	NuCare Pharmaceuticals, Inc.	30b89788-4d90-617e-e063-6394a90a29dd	2025-03-19	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Saptalis Pharmaceuticals, LLC.	8cbde037-da83-4390-8465-7e383eee9287	2025-03-03	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	NuCare Pharmaceuticals,Inc.	696cd64f-28dd-3dae-e053-2a91aa0a0c76	2025-02-13	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Hikma Pharmaceuticals USA Inc.	c940a2d5-09a5-413b-b5a1-d8da8907bafd	2025-01-29	Warnings, Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Good Neighbor Pharmacy 24 Hour Nasal Allergy	TRIAMCINOLONE ACETONIDE	Amerisource Bergen	cccf50ee-60e1-44a1-a353-5949e8f85c0a	2025-01-04	Warnings	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	Advanced Rx Pharmacy of Tennessee, LLC	f4c077f2-2609-2235-e053-2995a90a1b57	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Padagis Israel Pharmaceuticals Ltd	5d2fe6c2-3856-47f6-843f-077b2e1080a0	2024-12-31	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	MICRO LABS LIMITED	22608943-79b1-4795-9231-ac4e166309d2	2024-12-27	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	NuCare Pharmaceuticals,Inc.	dff0403f-1c0c-3333-e053-2a95a90a4c09	2024-12-24	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	TruPharma, LLC	888f2b6f-1d11-4774-9eab-714af40edb7d	2024-12-23	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	NuCare Pharmaceuticals,Inc.	a4d74513-0548-4f11-e053-2995a90a1830	2024-12-13	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	Mylan Institutional LLC	4015ad7d-46bf-454e-ac86-91fa5dd6a07b	2024-12-05	Warnings, Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Cosette Pharmaceuticals, Inc.	5397395a-2d13-9311-7cb2-c316339d4acc	2024-12-04	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	c29de67c-c4c7-412b-ae5f-b5562a95a8f9	2024-11-20	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	c2b12aa8-1875-489b-8d16-fb588ad3cf54	2024-11-20	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Saptalis Pharmaceuticals, LLC.	a77a31dd-048e-4a4d-b006-6913978d7438	2024-11-13	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	a7c85d92-734e-4175-b1a7-eaff97abc45c	2024-11-12	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.