Application 073193

Type: ANDA
Sponsor: TARO PHARM INDS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TOPICORT	DESOXIMETASONE	CREAM;TOPICAL	0.25%	No	Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A073193-001	TOPICORT	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	RS	1990-11-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A073193-001	AB

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A073193-001	TOPICORT	0.25%	CREAM / TOPICAL	AB	RS	1990-11-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073193-001	TOPICORT	0.25%	CREAM / TOPICAL	AB	RS	1990-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073193-001	TOPICORT	0.25%	CREAM / TOPICAL	AB	RS	1990-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073193-001	TOPICORT	0.25%	CREAM / TOPICAL	AB	RS	1990-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073193-001	TOPICORT	0.25%	CREAM / TOPICAL	AB	RS	1990-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073193-001	TOPICORT	0.25%	CREAM / TOPICAL	AB	RS	1990-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073193-001	TOPICORT	0.25%	CREAM / TOPICAL	AB	RS	1990-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073193-001	TOPICORT	0.25%	CREAM / TOPICAL	AB	RS	1990-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073193-001	TOPICORT	0.25%	CREAM / TOPICAL	AB	RS	1990-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073193-001	TOPICORT	0.25%	CREAM / TOPICAL	AB	RS	1990-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073193-001	TOPICORT	0.25%	CREAM / TOPICAL	AB	RS	1990-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073193-001	TOPICORT	0.25%	CREAM / TOPICAL	AB	RS	1990-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073193-001	TOPICORT	0.25%	CREAM / TOPICAL	AB	RS	1990-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073193-001	TOPICORT	0.25%	CREAM / TOPICAL	AB	RS	1990-11-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073193-001	TOPICORT	0.25%	CREAM / TOPICAL	AB	RS	1990-11-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073193-001	TOPICORT	0.25%	CREAM / TOPICAL	AB	RS	1990-11-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073193-001	TOPICORT	0.25%	CREAM / TOPICAL	AB	RS	1990-11-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073193-001	TOPICORT	0.25%	CREAM / TOPICAL	AB	RS	1990-11-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073193-001	TOPICORT	0.25%	CREAM / TOPICAL	AB	RS	1990-11-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073193-001	TOPICORT	0.25%	CREAM / TOPICAL	AB	RS	1990-11-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073193-001	TOPICORT	0.25%	CREAM / TOPICAL	AB	RS	1990-11-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073193-001	TOPICORT	0.25%	CREAM / TOPICAL	AB	RS	1990-11-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073193-001	TOPICORT	0.25%	CREAM / TOPICAL	AB	RS	1990-11-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073193-001	TOPICORT	0.25%	CREAM / TOPICAL	AB	RS	1990-11-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073193-001	TOPICORT	0.25%	CREAM / TOPICAL	AB	RS	1990-11-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073193-001	TOPICORT	0.25%	CREAM / TOPICAL	AB	RS	1990-11-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073193-001	TOPICORT	0.25%	CREAM / TOPICAL	AB	RS	1990-11-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073193-001	TOPICORT	0.25%	CREAM / TOPICAL	AB	RS	1990-11-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073193-001	TOPICORT	0.25%	CREAM / TOPICAL	AB	RS	1990-11-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073193-001	TOPICORT	0.25%	CREAM / TOPICAL	AB	RS	1990-11-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073193-001	TOPICORT	0.25%	CREAM / TOPICAL	AB	RS	1990-11-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073193-001	TOPICORT	0.25%	CREAM / TOPICAL	AB	RS	1990-11-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073193-001	TOPICORT	0.25%	CREAM / TOPICAL	AB	RS	1990-11-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073193-001	TOPICORT	0.25%	CREAM / TOPICAL	AB	RS	1990-11-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073193-001	TOPICORT	0.25%	CREAM / TOPICAL	AB	RS	1990-11-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073193-001	TOPICORT	0.25%	CREAM / TOPICAL	AB	RS	1990-11-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073193-001	TOPICORT	0.25%	CREAM / TOPICAL	AB	RS	1990-11-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073193-001	TOPICORT	0.25%	CREAM / TOPICAL	AB	RS	1990-11-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073193-001	TOPICORT	0.25%	CREAM / TOPICAL	AB	RS	1990-11-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A073193-001	TOPICORT	0.25%	CREAM / TOPICAL	AB	RS	1990-11-30	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A073193-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073193-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073193-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073193-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073193-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073193-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073193-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073193-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073193-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073193-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073193-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073193-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073193-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073193-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073193-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073193-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073193-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073193-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073193-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073193-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073193-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073193-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073193-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073193-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073193-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073193-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073193-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073193-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073193-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073193-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073193-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073193-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073193-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073193-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073193-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073193-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073193-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073193-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073193-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A073193-001	AB	1	`e64feba35796…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Desoximetasone	DESOXIMETASONE	Sun Pharmaceutical Industries, Inc.	37eb1205-1743-4480-8631-b0bbcaeb8359	2025-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073193 application number: ANDA073193 ndc (product): 51672-1270
Desoximetasone	DESOXIMETASONE	A-S Medication Solutions	0e72952e-8e9f-467a-8191-2bc157087d60	2023-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073193 application number: ANDA073193 ndc (product): 50090-5571

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
42254-015	Desoximetasone	Desoximetasone	Rebel Distributors Corp	ANDA	Current
50090-5571	Desoximetasone	Desoximetasone	A-S Medication Solutions	ANDA	Current
50090-5571	Desoximetasone	Desoximetasone	A-S Medication Solutions	ANDA	Current
51672-1270	Desoximetasone	Desoximetasone	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-5204	Topicort	Desoximetasone	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-5204	Topicort	Desoximetasone	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
68788-7703	Desoximetasone	Desoximetasone	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7703	Desoximetasone	Desoximetasone	Preferred Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8408	SUPPL	2015-08-27
18351	SUPPL	2015-08-26