Application 012041

Type: NDA
Sponsor: APOTHECON

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KENALOG-10	TRIAMCINOLONE ACETONIDE	INJECTABLE;INJECTION	10MG/ML	Yes	No

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

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
N012041-001	KENALOG-10	TRIAMCINOLONE ACETONIDE	10MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N012041-001	AB

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 2 of 2 · 44 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
2022-10-28 04:53 UTC	2022-10	N012041-001	KENALOG-10	10MG/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N012041-001	KENALOG-10	10MG/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N012041-001	KENALOG-10	10MG/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N012041-001	KENALOG-10	10MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N012041-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N012041-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N012041-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N012041-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012041-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N012041-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012041-001	AB	1	`fd3edfee7708…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N012041-001	AB	1	`a50c72e98297…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
KENALOG-10	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	653ec195-0966-478d-be47-6b1ff158e111	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 012041 application number: NDA012041 ndc (product): 50090-0295
KENALOG-10	TRIAMCINOLONE ACETONIDE	E.R. Squibb & Sons, L.L.C.	ec04ecbb-2896-3feb-85fd-a64aba93b289	2024-08-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 012041 application number: NDA012041 ndc (product): 0003-0494

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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0003-0494	KENALOG-10	TRIAMCINOLONE ACETONIDE	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0494	KENALOG-10	TRIAMCINOLONE ACETONIDE	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0494	KENALOG-10	TRIAMCINOLONE ACETONIDE	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0494	KENALOG-10	TRIAMCINOLONE ACETONIDE	E.R. Squibb & Sons, L.L.C.	NDA	Current
50090-0295	KENALOG-10	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	NDA	Current
50090-0295	KENALOG-10	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	NDA	Current
68258-8903	KENALOG-10	TRIAMCINOLONE ACETONIDE	Dispensing Solutions, Inc.	NDA	Current
70518-2460	KENALOG-10	TRIAMCINOLONE ACETONIDE	REMEDYREPACK INC.	NDA	Current
70518-2460	KENALOG-10	TRIAMCINOLONE ACETONIDE	REMEDYREPACK INC.	NDA	Current
70518-2460	KENALOG-10	TRIAMCINOLONE ACETONIDE	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79707	SUPPL	2024-09-24
79706	SUPPL	2024-09-24
78709	SUPPL	2024-06-07
78676	SUPPL	2024-06-06
54731	SUPPL	2018-06-29
54701	SUPPL	2018-06-27
53583	SUPPL	2018-04-01
53572	SUPPL	2018-04-01
33071	SUPPL	2014-07-09
11985	SUPPL	2014-07-08
40677	SUPPL	2012-02-28
11984	SUPPL	2011-07-19
33070	SUPPL	2011-07-18
302	SUPPL	2011-06-17
10791	SUPPL	2011-06-16
301	SUPPL	2010-02-05
33069	SUPPL	2010-02-04
11983	SUPPL	2006-12-04
33068	SUPPL	2006-11-22