Application 087385

Type: ANDA
Sponsor: PERRIGO NEW YORK

Application Products#

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

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	RLD / RS
A087385-001	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982
A087385-002	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982
A087385-003	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A087385-001	AT
A087385-002	AT
A087385-003	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 2 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087385-002	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087385-003	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087385-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087385-002	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087385-003	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087385-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087385-002	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087385-003	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087385-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A087385-002	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A087385-003	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087385-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087385-002	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087385-003	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087385-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A087385-002	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A087385-003	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087385-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A087385-002	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A087385-003	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087385-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	RS, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A087385-002	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	RS, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A087385-003	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087385-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A087385-002	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A087385-003	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087385-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A087385-002	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A087385-003	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087385-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	RS, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087385-002	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	RS, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087385-003	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087385-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	RS, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A087385-002	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	RS, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A087385-003	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087385-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	RS, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A087385-002	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	RS, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A087385-003	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087385-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	RS, Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A087385-002	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	RS, Approved before 1982	`c0c555d07b60…`

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	A087385-001	AT	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A087385-002	AT	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A087385-003	AT	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A087385-001	AT	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A087385-002	AT	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A087385-003	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A087385-001	AT	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A087385-002	AT	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A087385-003	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A087385-001	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A087385-002	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A087385-003	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087385-001	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087385-002	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087385-003	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087385-001	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A087385-002	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A087385-003	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087385-001	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087385-002	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087385-003	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087385-001	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087385-002	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087385-003	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087385-001	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087385-002	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087385-003	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087385-001	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087385-002	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087385-003	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087385-001	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087385-002	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087385-003	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087385-001	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087385-002	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087385-003	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087385-001	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A087385-002	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A087385-003	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087385-001	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 1 of 1 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	93041e9c-3320-4617-b1c1-68c95bf6b770	2026-09-23	Adverse reactions	Exact identifier application applno (ANDA): 087385 application number: ANDA087385 ndc (product): 50090-0362
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	6d565a2c-d145-425a-a87d-6d07a90ad2fe	2026-04-27	Adverse reactions	Exact identifier application applno (ANDA): 087385 application number: ANDA087385 ndc (product): 50090-5980
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	REMEDYREPACK INC.	809c8ef7-6313-412e-82c7-adaa824bb599	2026-04-15	Adverse reactions	Exact identifier application applno (ANDA): 087385 application number: ANDA087385
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	DIRECTRX	835bbcd1-3869-646c-e053-2a91aa0a796a	2026-03-17	Adverse reactions	Exact identifier application applno (ANDA): 087385 application number: ANDA087385 ndc (product): 61919-619
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	fab09252-d474-4894-bbbf-a95b14c78936	2025-11-26	Adverse reactions	Exact identifier application applno (ANDA): 087385 application number: ANDA087385
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	NuCare Pharmaceuticals,Inc.	a4d74513-0548-4f11-e053-2995a90a1830	2024-12-13	Adverse reactions	Exact identifier application applno (ANDA): 087385 application number: ANDA087385 ndc (product): 68071-1872
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	c29de67c-c4c7-412b-ae5f-b5562a95a8f9	2024-11-20	Adverse reactions	Exact identifier application applno (ANDA): 087385 application number: ANDA087385
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	658a80d1-1cd2-45a4-b097-6605c1ba31cd	2024-06-18	Adverse reactions	Exact identifier application applno (ANDA): 087385 application number: ANDA087385
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	c3b09e80-67a7-4c5f-b324-2d8ecc9c054e	2024-05-17	Adverse reactions	Exact identifier application applno (ANDA): 087385 application number: ANDA087385
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Proficient Rx LP	1bc85267-249f-4c55-9a8a-06d265263cb5	2023-12-01	Adverse reactions	Exact identifier application applno (ANDA): 087385 application number: ANDA087385
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Padagis Israel Pharmaceuticals Ltd	838ba2fa-5133-4975-bd99-791891a144c5	2023-10-01	Adverse reactions	Exact identifier application applno (ANDA): 087385 application number: ANDA087385 ndc (product): 45802-054 ndc (product): 45802-055 ndc (product): 45802-049
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Proficient Rx LP	63b51d50-7eb9-4687-965c-d4c57afc4030	2022-04-01	Adverse reactions	Exact identifier application applno (ANDA): 087385 application number: ANDA087385 ndc (product): 63187-495

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 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45802-049	Triamcinolone Acetonide	Triamcinolone Acetonide	Perrigo New York Inc	ANDA	Current
45802-049	Triamcinolone Acetonide	Triamcinolone Acetonide	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-049	Triamcinolone Acetonide	Triamcinolone Acetonide	Perrigo New York Inc	ANDA	Current
45802-054	Triamcinolone Acetonide	Triamcinolone Acetonide	Perrigo New York Inc	ANDA	Current
45802-054	Triamcinolone Acetonide	Triamcinolone Acetonide	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-055	Triamcinolone Acetonide	Triamcinolone Acetonide	Perrigo New York Inc	ANDA	Current
45802-055	Triamcinolone Acetonide	Triamcinolone Acetonide	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
50090-0362	Triamcinolone Acetonide	Triamcinolone Acetonide	A-S Medication Solutions	ANDA	Current
50090-0362	Triamcinolone Acetonide	Triamcinolone Acetonide	A-S Medication Solutions	ANDA	Current
50090-5980	Triamcinolone Acetonide	Triamcinolone Acetonide	A-S Medication Solutions	ANDA	Current
53002-0150	Triamcinolone Acetonide	Triamcinolone Acetonide	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-0150	Triamcinolone Acetonide	Triamcinolone Acetonide	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-9121	Triamcinolone Acetonide	Triamcinolone Acetonide	RPK Pharmaceuticals, Inc.	ANDA	Current
61919-619	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	DIRECTRX	ANDA	Current
63187-495	Triamcinolone Acetonide	Triamcinolone Acetonide	Proficient Rx LP	ANDA	Current
63187-495	Triamcinolone Acetonide	Triamcinolone Acetonide	Proficient Rx LP	ANDA	Current
63187-495	Triamcinolone Acetonide	Triamcinolone Acetonide	Proficient Rx LP	ANDA	Current
68071-1872	Triamcinolone Acetonide	Triamcinolone Acetonide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1872	Triamcinolone Acetonide	Triamcinolone Acetonide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68258-3978	Triamcinolone Acetonide	Triamcinolone Acetonide	Dispensing Solutions, Inc.	ANDA	Current