Application 210346

Type: ANDA
Sponsor: STRIDES PHARMA

Application Products#

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

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

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	Approval date
A210346-001	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	2019-02-11
A210346-002	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	2019-02-11
A210346-003	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.5%	CREAM / TOPICAL	2019-02-11

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 · 129 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
2026-09-14 22:38:34	2026-08	A210346-001	TRIAMCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL		2019-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210346-002	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL		2019-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210346-003	TRIAMCINOLONE ACETONIDE	0.5%	CREAM / TOPICAL		2019-02-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210346-001	TRIAMCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL		2019-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210346-002	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL		2019-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210346-003	TRIAMCINOLONE ACETONIDE	0.5%	CREAM / TOPICAL		2019-02-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210346-001	TRIAMCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL		2019-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210346-002	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL		2019-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210346-003	TRIAMCINOLONE ACETONIDE	0.5%	CREAM / TOPICAL		2019-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210346-001	TRIAMCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT	2019-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210346-002	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2019-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210346-003	TRIAMCINOLONE ACETONIDE	0.5%	CREAM / TOPICAL	AT	2019-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210346-001	TRIAMCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT	2019-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210346-002	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2019-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210346-003	TRIAMCINOLONE ACETONIDE	0.5%	CREAM / TOPICAL	AT	2019-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210346-001	TRIAMCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT	2019-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210346-002	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2019-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210346-003	TRIAMCINOLONE ACETONIDE	0.5%	CREAM / TOPICAL	AT	2019-02-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210346-001	TRIAMCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT	2019-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210346-002	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2019-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210346-003	TRIAMCINOLONE ACETONIDE	0.5%	CREAM / TOPICAL	AT	2019-02-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210346-001	TRIAMCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT	2019-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210346-002	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2019-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210346-003	TRIAMCINOLONE ACETONIDE	0.5%	CREAM / TOPICAL	AT	2019-02-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210346-001	TRIAMCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT	2019-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210346-002	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2019-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210346-003	TRIAMCINOLONE ACETONIDE	0.5%	CREAM / TOPICAL	AT	2019-02-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210346-001	TRIAMCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT	2019-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210346-002	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2019-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210346-003	TRIAMCINOLONE ACETONIDE	0.5%	CREAM / TOPICAL	AT	2019-02-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210346-001	TRIAMCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT	2019-02-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210346-002	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2019-02-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210346-003	TRIAMCINOLONE ACETONIDE	0.5%	CREAM / TOPICAL	AT	2019-02-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210346-001	TRIAMCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT	2019-02-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210346-002	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2019-02-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210346-003	TRIAMCINOLONE ACETONIDE	0.5%	CREAM / TOPICAL	AT	2019-02-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210346-001	TRIAMCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT	2019-02-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210346-002	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2019-02-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210346-003	TRIAMCINOLONE ACETONIDE	0.5%	CREAM / TOPICAL	AT	2019-02-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210346-001	TRIAMCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT	2019-02-11	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 117 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210346-001	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210346-002	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210346-003	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210346-001	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210346-002	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210346-003	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210346-001	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210346-002	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210346-003	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210346-001	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210346-002	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210346-003	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210346-001	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210346-002	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210346-003	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210346-001	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210346-002	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210346-003	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210346-001	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210346-002	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210346-003	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210346-001	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210346-002	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210346-003	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210346-001	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210346-002	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210346-003	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210346-001	AT	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210346-002	AT	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210346-003	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210346-001	AT	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210346-002	AT	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210346-003	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210346-001	AT	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210346-002	AT	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210346-003	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210346-001	AT	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210346-002	AT	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210346-003	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210346-001	AT	1	`5c6f7cd8ea54…`

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 8 of 11 · 209 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	69786597-99f9-4bdc-91bc-c50e5fd682c8	2024-06-26	Adverse reactions	Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	NuCare Pharmaceuticals,Inc.	8c4026de-9e91-c95d-e053-2a95a90a6903	2024-06-18	Adverse reactions	Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE
triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	107146d5-ffd2-4eb5-b75a-f814cd8407f0	2024-06-18	Adverse reactions	Name fallback brand name: triamcinolone acetonide generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	658a80d1-1cd2-45a4-b097-6605c1ba31cd	2024-06-18	Adverse reactions	Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE
triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	NuCare Pharmaceuticals,Inc.	69aec845-3d4a-d226-e053-2991aa0afd12	2024-06-10	Adverse reactions	Name fallback brand name: triamcinolone acetonide generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	NuCare Pharmaceuticals,Inc.	6a282425-8fdc-1fca-e053-2a91aa0a1c3a	2024-06-10	Adverse reactions	Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	NuCare Pharmaceuticals,Inc.	6543d747-46a3-0502-e053-2991aa0aa002	2024-06-06	Adverse reactions	Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	f85e36df-15d8-4b8f-94a5-39742d572804	2024-05-31	Adverse reactions	Name fallback brand name: TRIAMCINOLONE ACETONIDE generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	c3b09e80-67a7-4c5f-b324-2d8ecc9c054e	2024-05-17	Adverse reactions	Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	2229a9e5-144f-42be-ab12-9c4f4163d22a	2024-03-12	Adverse reactions	Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Proficient Rx LP	64d6a2f3-18cc-4ce4-8e75-4d77515e1911	2024-03-01	Adverse reactions	Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	7889440c-4e82-4eb2-b5d3-7c4e0d5bdd8d	2024-02-20	Adverse reactions	Name fallback brand name: TRIAMCINOLONE ACETONIDE generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Proficient Rx LP	de5bad69-a014-4e25-b1b9-214373ca57a5	2024-02-01	Adverse reactions	Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	ee274346-938b-4678-9146-486ca65bcba5	2024-01-15	Adverse reactions	Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	1e9007e8-fcd4-4aff-8d0a-4a43e0b8e673	2024-01-12	Adverse reactions	Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	2adb56d4-2883-4060-b8cb-65a7662cfdda	2024-01-12	Adverse reactions	Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE
Triloan II SUIK	TRIAMCINOLONE ACETONIDE	Asclemed USA, Inc.	af3d002d-5e8e-44f6-bdd9-45a99263221b	2024-01-09	Warnings, Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	b3d21abc-8952-45c3-b8cf-efa4dcce268d	2023-12-28	Adverse reactions	Name fallback brand name: Triamcinolone acetonide generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	NorthStar RxLLC	cc60731e-6cef-44b1-903c-13c6f4a76e70	2023-12-25	Adverse reactions	Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE
triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	2d6b9c2f-f1a0-413e-b333-64da52368202	2023-12-09	Adverse reactions	Name fallback brand name: triamcinolone acetonide generic name: TRIAMCINOLONE ACETONIDE

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
64380-800	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	Strides Pharma Science Limited	ANDA	Current
64380-800	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	Strides Pharma Science Limited	ANDA	Current
64380-801	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	Strides Pharma Science Limited	ANDA	Current
64380-801	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	Strides Pharma Science Limited	ANDA	Current
64380-802	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	Strides Pharma Science Limited	ANDA	Current
64380-802	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	Strides Pharma Science Limited	ANDA	Current