Application 088042

Type: ANDA
Sponsor: CROWN LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRIDERM	TRIAMCINOLONE ACETONIDE	CREAM;TOPICAL	0.1%	No	No
002	TRIDERM	TRIAMCINOLONE ACETONIDE	CREAM;TOPICAL	0.025%	No	No
003	TRIDERM	TRIAMCINOLONE ACETONIDE	CREAM;TOPICAL	0.5%	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A088042-001	TRIDERM	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	1984-03-19
A088042-002	TRIDERM	TRIAMCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT	2015-03-25
A088042-003	TRIDERM	TRIAMCINOLONE ACETONIDE	0.5%	CREAM / TOPICAL	AT	2015-03-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A088042-001	AT
A088042-002	AT
A088042-003	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 4 · 132 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
2026-10-15 13:18:30	2026-09	A088042-001	TRIDERM	0.1%	CREAM / TOPICAL	AT	1984-03-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A088042-002	TRIDERM	0.025%	CREAM / TOPICAL	AT	2015-03-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A088042-003	TRIDERM	0.5%	CREAM / TOPICAL	AT	2015-03-25	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A088042-001	TRIDERM	0.1%	CREAM / TOPICAL	AT	1984-03-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A088042-002	TRIDERM	0.025%	CREAM / TOPICAL	AT	2015-03-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A088042-003	TRIDERM	0.5%	CREAM / TOPICAL	AT	2015-03-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A088042-001	TRIDERM	0.1%	CREAM / TOPICAL	AT	1984-03-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A088042-002	TRIDERM	0.025%	CREAM / TOPICAL	AT	2015-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A088042-003	TRIDERM	0.5%	CREAM / TOPICAL	AT	2015-03-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088042-001	TRIDERM	0.1%	CREAM / TOPICAL	AT	1984-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A088042-002	TRIDERM	0.025%	CREAM / TOPICAL	AT	2015-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A088042-003	TRIDERM	0.5%	CREAM / TOPICAL	AT	2015-03-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088042-001	TRIDERM	0.1%	CREAM / TOPICAL	AT	1984-03-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088042-002	TRIDERM	0.025%	CREAM / TOPICAL	AT	2015-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088042-003	TRIDERM	0.5%	CREAM / TOPICAL	AT	2015-03-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088042-001	TRIDERM	0.1%	CREAM / TOPICAL	AT	1984-03-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A088042-002	TRIDERM	0.025%	CREAM / TOPICAL	AT	2015-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A088042-003	TRIDERM	0.5%	CREAM / TOPICAL	AT	2015-03-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088042-001	TRIDERM	0.1%	CREAM / TOPICAL	AT	1984-03-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088042-002	TRIDERM	0.025%	CREAM / TOPICAL	AT	2015-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088042-003	TRIDERM	0.5%	CREAM / TOPICAL	AT	2015-03-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088042-001	TRIDERM	0.1%	CREAM / TOPICAL	AT	1984-03-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088042-002	TRIDERM	0.025%	CREAM / TOPICAL	AT	2015-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088042-003	TRIDERM	0.5%	CREAM / TOPICAL	AT	2015-03-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088042-001	TRIDERM	0.1%	CREAM / TOPICAL	AT	1984-03-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088042-002	TRIDERM	0.025%	CREAM / TOPICAL	AT	2015-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088042-003	TRIDERM	0.5%	CREAM / TOPICAL	AT	2015-03-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088042-001	TRIDERM	0.1%	CREAM / TOPICAL	AT	1984-03-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088042-002	TRIDERM	0.025%	CREAM / TOPICAL	AT	2015-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088042-003	TRIDERM	0.5%	CREAM / TOPICAL	AT	2015-03-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088042-001	TRIDERM	0.1%	CREAM / TOPICAL	AT	1984-03-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088042-002	TRIDERM	0.025%	CREAM / TOPICAL	AT	2015-03-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088042-003	TRIDERM	0.5%	CREAM / TOPICAL	AT	2015-03-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088042-001	TRIDERM	0.1%	CREAM / TOPICAL	AT	1984-03-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088042-002	TRIDERM	0.025%	CREAM / TOPICAL	AT	2015-03-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088042-003	TRIDERM	0.5%	CREAM / TOPICAL	AT	2015-03-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088042-001	TRIDERM	0.1%	CREAM / TOPICAL	AT	1984-03-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A088042-002	TRIDERM	0.025%	CREAM / TOPICAL	AT	2015-03-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A088042-003	TRIDERM	0.5%	CREAM / TOPICAL	AT	2015-03-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088042-001	TRIDERM	0.1%	CREAM / TOPICAL	AT	1984-03-19	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A088042-001	AT	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A088042-002	AT	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A088042-003	AT	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A088042-001	AT	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A088042-002	AT	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A088042-003	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A088042-001	AT	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A088042-002	AT	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A088042-003	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088042-001	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A088042-002	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A088042-003	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088042-001	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088042-002	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088042-003	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088042-001	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A088042-002	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A088042-003	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088042-001	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088042-002	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088042-003	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088042-001	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088042-002	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088042-003	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088042-001	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088042-002	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088042-003	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088042-001	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088042-002	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088042-003	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088042-001	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088042-002	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088042-003	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088042-001	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088042-002	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088042-003	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088042-001	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A088042-002	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A088042-003	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088042-001	AT	1	`79d66fd596c7…`

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 2 of 2 · 30 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	Preferred Pharmaceuticals Inc.	d0428b54-c4f5-46f1-a65e-7e20c56dbe78	2025-07-10	Adverse reactions	Exact identifier application applno (ANDA): 088042 application number: ANDA088042
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	a7c85d92-734e-4175-b1a7-eaff97abc45c	2024-11-12	Adverse reactions	Exact identifier application applno (ANDA): 088042 application number: ANDA088042
Scarzen	TRIAMCINOLONE ACETONIDE, DIMETHICONE	Village Pharma LLC	4777b129-5f7e-49af-9cf7-65158fdf4348	2024-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088042 application number: ANDA088042 ndc (product): 71574-501
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	0bf47993-615c-4d89-8e02-145f59315362	2024-08-14	Adverse reactions	Exact identifier application applno (ANDA): 088042 application number: ANDA088042
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	NuCare Pharmaceuticals,Inc.	b43d4e4a-6206-4449-e053-2a95a90a721a	2024-07-17	Adverse reactions	Exact identifier application applno (ANDA): 088042 application number: ANDA088042
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	7889440c-4e82-4eb2-b5d3-7c4e0d5bdd8d	2024-02-20	Adverse reactions	Exact identifier application applno (ANDA): 088042 application number: ANDA088042
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	ad88de0e-6e01-4056-b259-841fb67d2db0	2023-10-30	Adverse reactions	Exact identifier application applno (ANDA): 088042 application number: ANDA088042
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	70116d71-97a9-4a9b-bf1d-e79c8ef596e2	2023-08-04	Adverse reactions	Exact identifier application applno (ANDA): 088042 application number: ANDA088042
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	Proficient Rx LP	7dc12943-7702-4c84-b507-2ea207d02460	2023-06-01	Adverse reactions	Exact identifier application applno (ANDA): 088042 application number: ANDA088042
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	Proficient Rx LP	7a2392c6-d26f-4def-8c7d-8b79e384c522	2022-10-01	Adverse reactions	Exact identifier application applno (ANDA): 088042 application number: ANDA088042 ndc (product): 71205-009

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 2 of 2 · 100 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68788-6981	Triamcinolone acetonide	Triamcinolone acetonide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6981	Triamcinolone acetonide	Triamcinolone acetonide	Preferred Pharmaceuticals	ANDA	Current
69329-250	Dermasilkrx SDSpak	Triamcinolone Acetonide Cream, Dimethicone Cream	Patchwerx Labs, Inc.	ANDA	Current
69329-290	Dermawerx SDS Pak	Triamcinolone Acetonide Cream, Dimethicone Cream	Patchwerx Labs, Inc.	ANDA	Current
69837-003	Sure ResultTAC Pak	TRIAMCINOLONE ACETONIDE, DIMETHICONE	International Brand Management, LLC	ANDA	Current
70518-1094	Triamcinolone acetonide	Triamcinolone acetonide	REMEDYREPACK INC.	ANDA	Current
70518-1094	Triamcinolone acetonide	Triamcinolone acetonide	REMEDYREPACK INC.	ANDA	Current
70518-1094	Triamcinolone acetonide	Triamcinolone acetonide	REMEDYREPACK INC.	ANDA	Current
70518-1524	Triamcinolone acetonide	Triamcinolone acetonide	REMEDYREPACK INC.	ANDA	Current
70518-1524	Triamcinolone acetonide	Triamcinolone acetonide	REMEDYREPACK INC.	ANDA	Current
70859-047	NuTriaRX CreamPak	RIAMCINOLONE ACETONIDE, dimethicone	Nucare Pharmaceuticals, Inc.	ANDA	Current
71205-009	Triamcinolone acetonide	Triamcinolone acetonide	Proficient Rx LP	ANDA	Current
71205-009	Triamcinolone acetonide	Triamcinolone acetonide	Proficient Rx LP	ANDA	Current
71205-009	Triamcinolone acetonide	Triamcinolone acetonide	Proficient Rx LP	ANDA	Current
71205-009	Triamcinolone acetonide	Triamcinolone acetonide	Proficient Rx LP	ANDA	Current
71574-501	Scarzen	Triamcinolone Acetonide, Dimethicone	Village Pharma LLC	ANDA	Current
71574-501	Scarzen	Triamcinolone Acetonide, Dimethicone	Village Pharma LLC	ANDA	Current
72189-039	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	Direct_Rx	ANDA	Current
72189-039	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	Direct_Rx	ANDA	Current
72189-039	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	Direct_Rx	ANDA	Current