Application 014901

Type: NDA
Sponsor: APOTHECON

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KENALOG-40	TRIAMCINOLONE ACETONIDE	INJECTABLE;INJECTION	40MG/ML	Yes	Yes
002	KENALOG-80	TRIAMCINOLONE ACETONIDE	INJECTABLE;INJECTION	80MG/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N014901-001	KENALOG-40	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982
N014901-002	KENALOG-80	TRIAMCINOLONE ACETONIDE	80MG/ML	INJECTABLE / INJECTION		RLD, RS	2019-04-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N014901-001	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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2022-03-09 01:35 UTC	2022-03	N014901-001	KENALOG-40	40MG/ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N014901-002	KENALOG-80	80MG/ML	INJECTABLE / INJECTION		RLD, RS	2019-04-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N014901-001	KENALOG-40	40MG/ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N014901-002	KENALOG-80	80MG/ML	INJECTABLE / INJECTION		RLD, RS	2019-04-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N014901-001	KENALOG-40	40MG/ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N014901-002	KENALOG-80	80MG/ML	INJECTABLE / INJECTION		RLD, RS	2019-04-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N014901-001	KENALOG-40	40MG/ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N014901-002	KENALOG-80	80MG/ML	INJECTABLE / INJECTION		RLD, RS	2019-04-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N014901-001	KENALOG-40	40MG/ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N014901-002	KENALOG-80	80MG/ML	INJECTABLE / INJECTION		RLD, RS	2019-04-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N014901-001	KENALOG-40	40MG/ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N014901-002	KENALOG-80	80MG/ML	INJECTABLE / INJECTION		RLD, RS	2019-04-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N014901-001	KENALOG-40	40MG/ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N014901-002	KENALOG-80	80MG/ML	INJECTABLE / INJECTION		RLD, RS	2019-04-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N014901-001	KENALOG-40	40MG/ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N014901-002	KENALOG-80	80MG/ML	INJECTABLE / INJECTION		RLD, RS	2019-04-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N014901-001	KENALOG-40	40MG/ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N014901-002	KENALOG-80	80MG/ML	INJECTABLE / INJECTION		RLD, RS	2019-04-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N014901-001	KENALOG-40	40MG/ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982		`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N014901-002	KENALOG-80	80MG/ML	INJECTABLE / INJECTION		RLD, RS	2019-04-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N014901-001	KENALOG-40	40MG/ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982		`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N014901-002	KENALOG-80	80MG/ML	INJECTABLE / INJECTION		RLD, RS	2019-04-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N014901-001	KENALOG-40	40MG/ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982		`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N014901-002	KENALOG-80	80MG/ML	INJECTABLE / INJECTION		RLD, RS	2019-04-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N014901-001	KENALOG-40	40MG/ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982		`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N014901-002	KENALOG-80	80MG/ML	INJECTABLE / INJECTION		RLD, RS	2019-04-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N014901-001	KENALOG-40	40MG/ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982		`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N014901-002	KENALOG-80	80MG/ML	INJECTABLE / INJECTION		RLD, RS	2019-04-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N014901-001	KENALOG-40	40MG/ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982		`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N014901-002	KENALOG-80	80MG/ML	INJECTABLE / INJECTION		RLD, RS	2019-04-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N014901-001	KENALOG-40	40MG/ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982		`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N014901-002	KENALOG-80	80MG/ML	INJECTABLE / INJECTION		RLD, RS	2019-04-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N014901-001	KENALOG-40	40MG/ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982		`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N014901-002	KENALOG-80	80MG/ML	INJECTABLE / INJECTION		RLD, RS	2019-04-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N014901-001	KENALOG-40	40MG/ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982		`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N014901-002	KENALOG-80	80MG/ML	INJECTABLE / INJECTION		RLD, RS	2019-04-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N014901-001	KENALOG-40	40MG/ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982		`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N014901-002	KENALOG-80	80MG/ML	INJECTABLE / INJECTION		RLD, RS	2019-04-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N014901-001	KENALOG-40	40MG/ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982		`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N014901-002	KENALOG-80	80MG/ML	INJECTABLE / INJECTION		RLD, RS	2019-04-12	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N014901-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N014901-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N014901-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N014901-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N014901-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N014901-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N014901-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N014901-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N014901-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N014901-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N014901-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N014901-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N014901-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N014901-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N014901-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N014901-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N014901-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N014901-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N014901-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N014901-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N014901-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N014901-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N014901-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N014901-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N014901-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N014901-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N014901-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N014901-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N014901-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N014901-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N014901-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N014901-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N014901-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N014901-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N014901-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N014901-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N014901-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N014901-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N014901-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N014901-001	AB	1	`f41ea6bd6efb…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
KENALOG-40	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	4ce116aa-b330-4da9-9cdd-ba8e6be0c4ad	2026-01-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 014901 application number: NDA014901 ndc (product): 50090-0819
KENALOG-40	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	d26b97b8-edc8-4b93-b6b9-429016208ff9	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 014901 application number: NDA014901 ndc (product): 50090-2360
KENALOG-40	TRIAMCINOLONE ACETONIDE	E.R. Squibb & Sons, L.L.C.	cf970688-cd77-b95c-4bd9-c541590e9722	2024-08-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 014901 application number: NDA014901 ndc (product): 0003-0293 ndc (product): 0003-0315
KENALOG-40	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	cb0480b8-44ee-4506-b484-dc776c3092dc	2023-06-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 014901 application number: NDA014901 ndc (product): 50090-0256
KENALOG-40	TRIAMCINOLONE ACETONIDE	Proficient Rx LP	1ed85825-cd03-4b5b-9c9a-946653b5f71a	2023-01-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 014901 application number: NDA014901 ndc (product): 63187-661
KENALOG-40	TRIAMCINOLONE ACETONIDE	Asclemed USA, Inc.	0bc9c75f-963c-40b0-995b-dfcbd50371a5	2020-05-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 014901 application number: NDA014901 ndc (product): 76420-085

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 · 54 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0003-0293	KENALOG-40	TRIAMCINOLONE ACETONIDE	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0293	KENALOG-40	TRIAMCINOLONE ACETONIDE	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0293	KENALOG-40	TRIAMCINOLONE ACETONIDE	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0293	KENALOG-40	TRIAMCINOLONE ACETONIDE	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0293	KENALOG-40	TRIAMCINOLONE ACETONIDE	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0315	KENALOG-80	TRIAMCINOLONE ACETONIDE	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0315	KENALOG-80	TRIAMCINOLONE ACETONIDE	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0315	KENALOG-80	TRIAMCINOLONE ACETONIDE	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0315	KENALOG-80	TRIAMCINOLONE ACETONIDE	E.R. Squibb & Sons, L.L.C.	NDA	Current
21695-360	KENALOG-40	TRIAMCINOLONE ACETONIDE	Rebel Distributors	NDA	Current
49836-004	P-Care K40MX	Triamcinolone Acetonide, Bupivacaine HCl, Lidocaine HCl, Sodium Chloride, Povidone Iodine, Isopropyl Alcohol	RX PHARMA-PACK, INC.	NDA	Current
49836-004	P-Care K40MX	Triamcinolone Acetonide, Bupivacaine HCl, Lidocaine HCl, Sodium Chloride, Povidone Iodine, Isopropyl Alcohol	RX PHARMA-PACK, INC.	NDA	Current
49836-004	P-Care K40MX	Triamcinolone Acetonide, Bupivacaine HCl, Lidocaine HCl, Sodium Chloride, Povidone Iodine, Isopropyl Alcohol	RX PHARMA-PACK, INC.	NDA	Current
49836-005	P-Care K40G	Triamcinolone Acetonide, Povidone-Iodine, Isopropyl Alcohol	RX PHARMA-PACK, INC.	NDA	Current
49836-005	P-Care K40G	Triamcinolone Acetonide, Povidone-Iodine, Isopropyl Alcohol	RX PHARMA-PACK, INC.	NDA	Current
49836-005	P-Care K40G	Triamcinolone Acetonide, Povidone-Iodine, Isopropyl Alcohol	RX PHARMA-PACK, INC.	NDA	Current
49836-006	P-Care K40	triamcinolone acetonide, povidone-iodine, isopropyl alcohol	RX PHARMA-PACK, INC.	NDA	Current
49836-006	P-Care K40	triamcinolone acetonide, povidone-iodine, isopropyl alcohol	RX PHARMA-PACK, INC.	NDA	Current
49836-006	P-Care K40	triamcinolone acetonide, povidone-iodine, isopropyl alcohol	RX PHARMA-PACK, INC.	NDA	Current
49836-007	P-Care K80MX	Triamcinolone Acetonide, Bupivacaine HCl, Lidocaine HCl, Sodium Chloride, Povidone Iodine, Isopropyl Alcohol	RX PHARMA-PACK, INC.	NDA	Current
49836-007	P-Care K80MX	Triamcinolone Acetonide, Bupivacaine HCl, Lidocaine HCl, Sodium Chloride, Povidone Iodine, Isopropyl Alcohol	RX PHARMA-PACK, INC.	NDA	Current
49836-007	P-Care K80MX	Triamcinolone Acetonide, Bupivacaine HCl, Lidocaine HCl, Sodium Chloride, Povidone Iodine, Isopropyl Alcohol	RX PHARMA-PACK, INC.	NDA	Current
49836-008	P-Care K80	Triamcinolone Acetonide, Povidone Iodine, Isopropyl Alcohol	RX PHARMA-PACK, INC.	NDA	Current
49836-008	P-Care K80	Triamcinolone Acetonide, Povidone Iodine, Isopropyl Alcohol	RX PHARMA-PACK, INC.	NDA	Current
49836-008	P-Care K80	Triamcinolone Acetonide, Povidone Iodine, Isopropyl Alcohol	RX PHARMA-PACK, INC.	NDA	Current
49836-009	P-Care K80G	Triamcinolone Acetonide, Povidone-Iodine, Isopropyl Alcohol	RX PHARMA-PACK, INC.	NDA	Current
49836-009	P-Care K80G	Triamcinolone Acetonide, Povidone-Iodine, Isopropyl Alcohol	RX PHARMA-PACK, INC.	NDA	Current
49836-009	P-Care K80G	Triamcinolone Acetonide, Povidone-Iodine, Isopropyl Alcohol	RX PHARMA-PACK, INC.	NDA	Current
49836-524	JTT Physicians	triamcinolone acetonide,lidocaine hydrochloride, povidone iodine, ammonia	RX PHARMA-PACK, INC.	NDA	Current
49836-524	JTT Physicians	triamcinolone acetonide,lidocaine hydrochloride, povidone iodine, ammonia	RX PHARMA-PACK, INC.	NDA	Current
50090-0256	KENALOG-40	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	NDA	Current
50090-0256	KENALOG-40	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	NDA	Current
50090-0256	KENALOG-40	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	NDA	Current
50090-0256	KENALOG-40	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	NDA	Current
50090-0819	KENALOG-40	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	NDA	Current
50090-0819	KENALOG-40	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	NDA	Current
50090-0819	KENALOG-40	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	NDA	Current
50090-2360	KENALOG-40	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	NDA	Current
50090-2360	KENALOG-40	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	NDA	Current
55045-3248	KENALOG-40	TRIAMCINOLONE ACETONIDE	Dispensing Solutions, Inc.	NDA	Current
63187-349	Interarticular Joint Kit	AMMONIA, LIDOCAINE HYDROCHLORIDE ANHYDROUS, TRIAMCINOLONE ACETONIDE, POVIDONE-IODINE	Proficient Rx LP	NDA	Current
63187-661	KENALOG-40	TRIAMCINOLONE ACETONIDE	Proficient Rx LP	NDA	Current
63187-661	KENALOG-40	TRIAMCINOLONE ACETONIDE	Proficient Rx LP	NDA	Current
63187-661	KENALOG-40	TRIAMCINOLONE ACETONIDE	Proficient Rx LP	NDA	Current
69263-820	Pro-C-Dure 5 Kit	kenalog	Oaklock, LLC	NDA	Current
69263-820	Pro-C-Dure 5 Kit	kenalog	Oaklock, LLC	NDA	Current
69263-821	Pro-C-Dure 6 Kit	kenalog	Oaklock, LLC	NDA	Current
69263-821	Pro-C-Dure 6 Kit	kenalog	Oaklock, LLC	NDA	Current
69420-4001	BT	bupivacaine hydrochloride, triamcinolone acetonide, povidone-iodine and isopropyl alcohol	SA3, LLC	NDA	Current
69420-4002	LT	lidocaine hydrochloride, triamcinolone acetonide, povidone-iodine and isopropyl alcohol	SA3, LLC	NDA	Current
70518-0075	KENALOG-40	TRIAMCINOLONE ACETONIDE	REMEDYREPACK INC.	NDA	Current
70518-0075	KENALOG-40	TRIAMCINOLONE ACETONIDE	REMEDYREPACK INC.	NDA	Current
70518-0075	KENALOG-40	TRIAMCINOLONE ACETONIDE	REMEDYREPACK INC.	NDA	Current
76420-085	KENALOG-40	TRIAMCINOLONE ACETONIDE	Asclemed USA, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80227	SUPPL	2024-11-18
80226	SUPPL	2024-11-18
78715	SUPPL	2024-06-07
78680	SUPPL	2024-06-06
63095	SUPPL	2020-05-19
63087	SUPPL	2020-05-19
54712	SUPPL	2018-06-28
53581	SUPPL	2018-04-01
53573	SUPPL	2018-04-01
48411	SUPPL	2017-05-17
10852	SUPPL	2014-07-09
391	SUPPL	2014-07-08
12075	SUPPL	2011-07-19
33128	SUPPL	2011-07-18
390	SUPPL	2011-06-17
33127	SUPPL	2011-06-16
12074	SUPPL	2010-02-05
10851	SUPPL	2010-02-04
40699	SUPPL	2009-01-12
40698	SUPPL	2009-01-12
40697	SUPPL	2009-01-12
20047	SUPPL	2009-01-12
20046	SUPPL	2009-01-12
389	SUPPL	2006-12-04
10850	SUPPL	2006-11-22