Application 212384

Type: ANDA
Sponsor: ENCUBE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	OINTMENT;TOPICAL	0.05%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A212384-001	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT	RS	2019-11-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212384-001	AT

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.

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
2026-02-19 14:30 UTC	2026-02	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT	RS	2019-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT	RS	2019-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT	RS	2019-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT	RS	2019-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT	RS	2019-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT	RS	2019-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT	RS	2019-11-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT	RS	2019-11-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT	RS	2019-11-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT	RS	2019-11-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT	RS	2019-11-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT	RS	2019-11-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT	RS	2019-11-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT	RS	2019-11-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT		2019-11-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT		2019-11-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT		2019-11-29	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT		2019-11-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT		2019-11-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT		2019-11-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT		2019-11-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT		2019-11-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT		2019-11-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT		2019-11-29	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT	RS	2019-11-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT	RS	2019-11-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT	RS	2019-11-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT		2019-11-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT		2019-11-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT		2019-11-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT		2019-11-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT		2019-11-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT		2019-11-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT		2019-11-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT		2019-11-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT		2019-11-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT		2019-11-29	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT	RS	2019-11-29	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212384-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212384-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212384-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212384-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212384-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212384-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212384-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212384-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212384-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212384-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212384-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212384-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212384-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212384-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212384-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212384-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212384-001	AT	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212384-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212384-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212384-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212384-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212384-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212384-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212384-001	AT	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212384-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212384-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212384-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212384-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212384-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212384-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212384-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212384-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212384-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212384-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212384-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212384-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212384-001	AT	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212384-001	AT	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2020-12-22 03:56 UTC	2020-12	A212384-001	CGT	2020-05-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212384-001	CGT	2020-05-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212384-001	CGT	2020-05-30	`3f01610625f2…`

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
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE OINTMENT USP, 0.05%	Encube Ethicals, Inc.	a20baaac-002d-40ac-9c7b-f92e8ee987ea	2025-09-25	Adverse reactions	Exact identifier application applno (ANDA): 212384 application number: ANDA212384 ndc (product): 21922-024
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE OINTMENT USP, 0.05%	Northstar Rx LLC	fb7c85fa-56f1-4cb1-821d-0f6c9adc83f6	2024-09-03	Adverse reactions	Exact identifier application applno (ANDA): 212384 application number: ANDA212384

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
21922-024	Triamcinolone Acetonide	Triamcinolone Acetonide Ointment USP, 0.05%	Encube Ethicals Private Limited	ANDA	Current
21922-024	Triamcinolone Acetonide	Triamcinolone Acetonide Ointment USP, 0.05%	Encube Ethicals Private Limited	ANDA	Current
51862-290	triamcinolone acetonide	triamcinolone acetonide	Mayne Pharma Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
61130	ORIG	2019-12-03