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TRIAMCINOLONE ACETONIDE	LOTION;TOPICAL	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No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KENALOG	TRIAMCINOLONE ACETONIDE	LOTION;TOPICAL	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No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A084343-001	KENALOG	TRIAMCINOLONE ACETONIDE	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		Approved before 1982
A084343-002	KENALOG	TRIAMCINOLONE ACETONIDE	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		Approved before 1982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A084343-001	KENALOG	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	Approved before 1982	`c2088c7a36db…`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A084343-002	KENALOG	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	Approved before 1982	`c2088c7a36db…`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A084343-001	KENALOG	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	Approved before 1982	`84e616aacf4f…`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 9 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	A-S Medication Solutions	0d40e68d-feb5-4061-8b43-515b2f553371	2023-07-31	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	e4e2aeed-e9c4-4f35-8cd2-7439785d9ffb	2023-07-17	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	9c418bf0-7de3-4389-81e8-b1e2887af7c5	2023-07-11	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Macleods Pharmaceuticals Limited	5873c78d-a9d4-49fc-95b8-5d4a368e9109	2023-07-01	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	Macleods Pharmaceuticals Limited	4dc6fa38-0225-4b99-8cef-4fee72a30f90	2023-07-01	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
foster and thrive 24 hour nasal allergy	TRIAMCINOLONE ACETONIDE	Strategic Sourcing Services LLC	eb5e5496-d270-4c26-aac1-0506f458d45b	2023-06-30	Warnings	Name fallback generic name: TRIAMCINOLONE ACETONIDE
KENALOG-40	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	cb0480b8-44ee-4506-b484-dc776c3092dc	2023-06-15	Warnings, Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	Proficient Rx LP	7dc12943-7702-4c84-b507-2ea207d02460	2023-06-01	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Padagis Israel Pharmaceuticals Ltd	8c8307ed-d0c9-4f74-84a8-1471677a4f2a	2023-05-01	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	c21c3a96-d491-4a60-a09e-d0eccd34b20f	2023-02-28	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	QUAGEN PHARMACEUTICALS LLC	22c80caa-730e-41c4-b772-18a369e76885	2023-02-15	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Proficient Rx LP	4aa792cc-7cd4-4a98-8730-fa36feaa9b7a	2023-02-01	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triasil	TRIAMCINOLONE ACETONIDE	PureTek Corporation	dcf6c630-6f5d-3d2f-e053-2995a90ad812	2023-01-24	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	CMP Pharma, Inc.	5067e7da-3eed-4d6a-b870-47a35c3ded81	2023-01-17	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
KENALOG-40	TRIAMCINOLONE ACETONIDE	Proficient Rx LP	1ed85825-cd03-4b5b-9c9a-946653b5f71a	2023-01-01	Warnings, Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	Padagis Israel Pharmaceuticals Ltd	3cb47c24-b7eb-4709-8a41-cbeceadbc8d9	2023-01-01	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Cosette Pharmaceuticals, Inc.	b93b6763-446b-3277-497b-2ee50dcef80c	2022-11-30	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Cosette Pharmaceuticals, Inc.	d2095a36-3fcf-7c20-95e5-e046b014565f	2022-11-29	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Cosette Pharmaceuticals, Inc.	5b3bcc75-608d-23fd-91a5-0806d5fe32f5	2022-11-18	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Signature Care Nasal Allergy	TRIAMCINOLONE ACETONIDE	Safeway	65761d58-312a-4ae9-b75b-2fe3fa5f7092	2022-11-15	Warnings	Name fallback generic name: TRIAMCINOLONE ACETONIDE

Reported adverse events (FAERS/openFDA)#

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