Application 209828

Type: ANDA
Sponsor: MACLEODS PHARMS LTD

Application Products#

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

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

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
A209828-001	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	2018-11-23
A209828-002	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	2018-11-23
A209828-003	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2018-11-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209828-001	AT
A209828-002	AT
A209828-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A209828-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	2018-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209828-002	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	2018-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209828-003	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2018-11-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209828-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	2018-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209828-002	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	2018-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209828-003	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2018-11-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209828-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	2018-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209828-002	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	2018-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209828-003	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2018-11-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209828-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	2018-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209828-002	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	2018-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209828-003	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2018-11-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209828-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	2018-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209828-002	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	2018-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209828-003	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2018-11-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209828-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	2018-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209828-002	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	2018-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209828-003	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2018-11-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209828-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	2018-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209828-002	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	2018-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209828-003	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2018-11-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209828-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	2018-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209828-002	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	2018-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209828-003	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2018-11-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209828-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	2018-11-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209828-002	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	2018-11-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209828-003	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2018-11-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209828-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	2018-11-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209828-002	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	2018-11-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209828-003	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2018-11-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209828-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	2018-11-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209828-002	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	2018-11-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209828-003	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2018-11-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209828-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	2018-11-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209828-002	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	2018-11-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209828-003	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2018-11-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209828-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	2018-11-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209828-002	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	2018-11-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209828-003	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2018-11-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209828-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	2018-11-23	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209828-001	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209828-002	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209828-003	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209828-001	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209828-002	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209828-003	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209828-001	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209828-002	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209828-003	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209828-001	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209828-002	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209828-003	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209828-001	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209828-002	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209828-003	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209828-001	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209828-002	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209828-003	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209828-001	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209828-002	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209828-003	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209828-001	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209828-002	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209828-003	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209828-001	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209828-002	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209828-003	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209828-001	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209828-002	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209828-003	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209828-001	AT	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209828-002	AT	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209828-003	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209828-001	AT	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209828-002	AT	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209828-003	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209828-001	AT	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209828-002	AT	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209828-003	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209828-001	AT	1	`8072bd15b7f6…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	NuCare Pharmaceuticals,Inc.	bd465674-3527-1590-e053-2995a90a958d	2026-02-19	Adverse reactions	Exact identifier application applno (ANDA): 209828 application number: ANDA209828 ndc (product): 68071-2362
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	REMEDYREPACK INC.	037efc03-22ab-45eb-9b0e-b125e4b5eb99	2026-01-20	Adverse reactions	Exact identifier application applno (ANDA): 209828 application number: ANDA209828
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	REMEDYREPACK INC.	d10b5451-5685-489e-b123-55c99d33c5b2	2025-09-29	Adverse reactions	Exact identifier application applno (ANDA): 209828 application number: ANDA209828
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	NorthStar RxLLC	3379f247-4a29-4373-9843-0b7f044c2276	2025-04-03	Adverse reactions	Exact identifier application applno (ANDA): 209828 application number: ANDA209828 ndc (product): 16714-268 ndc (product): 16714-267
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	b3d21abc-8952-45c3-b8cf-efa4dcce268d	2023-12-28	Adverse reactions	Exact identifier application applno (ANDA): 209828 application number: ANDA209828
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	Proficient Rx LP	6bb0edc7-643b-4b20-aa48-ee3b22bce575	2023-10-01	Adverse reactions	Exact identifier application applno (ANDA): 209828 application number: ANDA209828
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	Macleods Pharmaceuticals Limited	4dc6fa38-0225-4b99-8cef-4fee72a30f90	2023-07-01	Adverse reactions	Exact identifier application applno (ANDA): 209828 application number: ANDA209828 ndc (product): 33342-331 ndc (product): 33342-332 ndc (product): 33342-333

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-267	Triamcinolone acetonide	Triamcinolone acetonide	NorthStar RxLLC	ANDA	Current
16714-268	Triamcinolone acetonide	Triamcinolone acetonide	NorthStar RxLLC	ANDA	Current
33342-331	Triamcinolone acetonide	Triamcinolone acetonide	Macleods Pharmaceuticals Limited	ANDA	Current
33342-332	Triamcinolone acetonide	Triamcinolone acetonide	Macleods Pharmaceuticals Limited	ANDA	Current
33342-333	Triamcinolone acetonide	Triamcinolone acetonide	Macleods Pharmaceuticals Limited	ANDA	Current
68071-2362	Triamcinolone acetonide	Triamcinolone acetonide	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-3373	Triamcinolone acetonide	Triamcinolone acetonide	REMEDYREPACK INC.	ANDA	Current
70518-3373	Triamcinolone acetonide	Triamcinolone acetonide	REMEDYREPACK INC.	ANDA	Current