Application 213559

Type: ANDA
Sponsor: QUAGEN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	LOTION;TOPICAL	0.025%	No	No
002	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	LOTION;TOPICAL	0.1%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A213559-001	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.025%	LOTION / TOPICAL	AT		2020-07-01
A213559-002	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT		2020-07-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A213559-001	AT
A213559-002	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.

Product history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A213559-001	TRIAMCINOLONE ACETONIDE	0.025%	LOTION / TOPICAL	AT	2020-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213559-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2020-07-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213559-001	TRIAMCINOLONE ACETONIDE	0.025%	LOTION / TOPICAL	AT	2020-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213559-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2020-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213559-001	TRIAMCINOLONE ACETONIDE	0.025%	LOTION / TOPICAL	AT	2020-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213559-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2020-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213559-001	TRIAMCINOLONE ACETONIDE	0.025%	LOTION / TOPICAL	AT	2020-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213559-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2020-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213559-001	TRIAMCINOLONE ACETONIDE	0.025%	LOTION / TOPICAL	AT	2020-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213559-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2020-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213559-001	TRIAMCINOLONE ACETONIDE	0.025%	LOTION / TOPICAL	AT	2020-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213559-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2020-07-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213559-001	TRIAMCINOLONE ACETONIDE	0.025%	LOTION / TOPICAL	AT	2020-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213559-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2020-07-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213559-001	TRIAMCINOLONE ACETONIDE	0.025%	LOTION / TOPICAL	AT	2020-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213559-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2020-07-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213559-001	TRIAMCINOLONE ACETONIDE	0.025%	LOTION / TOPICAL	AT	2020-07-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213559-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2020-07-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213559-001	TRIAMCINOLONE ACETONIDE	0.025%	LOTION / TOPICAL	AT	2020-07-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213559-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2020-07-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213559-001	TRIAMCINOLONE ACETONIDE	0.025%	LOTION / TOPICAL	AT	2020-07-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213559-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2020-07-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213559-001	TRIAMCINOLONE ACETONIDE	0.025%	LOTION / TOPICAL	AT	2020-07-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213559-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2020-07-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213559-001	TRIAMCINOLONE ACETONIDE	0.025%	LOTION / TOPICAL	AT	2020-07-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213559-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2020-07-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213559-001	TRIAMCINOLONE ACETONIDE	0.025%	LOTION / TOPICAL	AT	2020-07-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213559-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2020-07-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213559-001	TRIAMCINOLONE ACETONIDE	0.025%	LOTION / TOPICAL	AT	2020-07-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213559-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2020-07-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213559-001	TRIAMCINOLONE ACETONIDE	0.025%	LOTION / TOPICAL	AT	2020-07-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213559-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2020-07-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213559-001	TRIAMCINOLONE ACETONIDE	0.025%	LOTION / TOPICAL	AT	2020-07-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213559-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2020-07-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213559-001	TRIAMCINOLONE ACETONIDE	0.025%	LOTION / TOPICAL	AT	2020-07-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213559-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2020-07-01	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213559-001	TRIAMCINOLONE ACETONIDE	0.025%	LOTION / TOPICAL	AT	2020-07-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213559-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2020-07-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213559-001	TRIAMCINOLONE ACETONIDE	0.025%	LOTION / TOPICAL	AT	2020-07-01	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213559-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2020-07-01	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A213559-001	AT	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213559-002	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213559-001	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213559-002	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213559-001	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213559-002	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213559-001	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213559-002	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213559-001	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213559-002	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213559-001	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213559-002	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213559-001	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213559-002	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213559-001	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213559-002	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213559-001	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213559-002	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213559-001	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213559-002	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213559-001	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213559-002	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213559-001	AT	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213559-002	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213559-001	AT	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213559-002	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213559-001	AT	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213559-002	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213559-001	AT	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213559-002	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213559-001	AT	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213559-002	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213559-001	AT	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213559-002	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213559-001	AT	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213559-002	AT	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213559-001	AT	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213559-002	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213559-001	AT	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213559-002	AT	1	`782e0a99824c…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	QUAGEN PHARMACEUTICALS LLC	4c6ff738-60a3-4339-8e94-26fb9df65841	2025-07-22	Adverse reactions	Exact identifier application applno (ANDA): 213559 application number: ANDA213559 ndc (product): 70752-129 ndc (product): 70752-130
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	3d709ea2-060f-4b16-b1fd-191fb4484312	2024-08-15	Adverse reactions	Exact identifier application applno (ANDA): 213559 application number: ANDA213559
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	f85e36df-15d8-4b8f-94a5-39742d572804	2024-05-31	Adverse reactions	Exact identifier application applno (ANDA): 213559 application number: ANDA213559

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70752-129	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	QUAGEN PHARMACEUTICALS LLC	ANDA	Current
70752-129	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	QUAGEN PHARMACEUTICALS LLC	ANDA	Current
70752-130	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	QUAGEN PHARMACEUTICALS LLC	ANDA	Current
70752-130	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	QUAGEN PHARMACEUTICALS LLC	ANDA	Current