Application 210753

Type: ANDA
Sponsor: TELIGENT PHARMA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIFLORASONE DIACETATE	DIFLORASONE DIACETATE	OINTMENT;TOPICAL	0.05%	No	No

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

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
A210753-001	DIFLORASONE DIACETATE	DIFLORASONE DIACETATE	0.05%	OINTMENT / TOPICAL	AB		2018-06-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210753-001	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 · 41 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	A210753-001	DIFLORASONE DIACETATE	0.05%	OINTMENT / TOPICAL	AB	2018-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210753-001	DIFLORASONE DIACETATE	0.05%	OINTMENT / TOPICAL	AB	2018-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210753-001	DIFLORASONE DIACETATE	0.05%	OINTMENT / TOPICAL	AB	2018-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210753-001	DIFLORASONE DIACETATE	0.05%	OINTMENT / TOPICAL	AB	2018-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210753-001	DIFLORASONE DIACETATE	0.05%	OINTMENT / TOPICAL	AB	2018-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210753-001	DIFLORASONE DIACETATE	0.05%	OINTMENT / TOPICAL	AB	2018-06-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210753-001	DIFLORASONE DIACETATE	0.05%	OINTMENT / TOPICAL	AB	2018-06-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210753-001	DIFLORASONE DIACETATE	0.05%	OINTMENT / TOPICAL	AB	2018-06-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210753-001	DIFLORASONE DIACETATE	0.05%	OINTMENT / TOPICAL	AB	2018-06-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210753-001	DIFLORASONE DIACETATE	0.05%	OINTMENT / TOPICAL	AB	2018-06-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210753-001	DIFLORASONE DIACETATE	0.05%	OINTMENT / TOPICAL	AB	2018-06-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210753-001	DIFLORASONE DIACETATE	0.05%	OINTMENT / TOPICAL	AB	2018-06-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210753-001	DIFLORASONE DIACETATE	0.05%	OINTMENT / TOPICAL	AB	2018-06-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210753-001	DIFLORASONE DIACETATE	0.05%	OINTMENT / TOPICAL	AB	2018-06-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210753-001	DIFLORASONE DIACETATE	0.05%	OINTMENT / TOPICAL	AB	2018-06-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210753-001	DIFLORASONE DIACETATE	0.05%	OINTMENT / TOPICAL	AB	2018-06-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210753-001	DIFLORASONE DIACETATE	0.05%	OINTMENT / TOPICAL	AB	2018-06-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210753-001	DIFLORASONE DIACETATE	0.05%	OINTMENT / TOPICAL	AB	2018-06-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210753-001	DIFLORASONE DIACETATE	0.05%	OINTMENT / TOPICAL	AB	2018-06-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210753-001	DIFLORASONE DIACETATE	0.05%	OINTMENT / TOPICAL	AB	2018-06-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210753-001	DIFLORASONE DIACETATE	0.05%	OINTMENT / TOPICAL	AB	2018-06-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210753-001	DIFLORASONE DIACETATE	0.05%	OINTMENT / TOPICAL	AB	2018-06-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210753-001	DIFLORASONE DIACETATE	0.05%	OINTMENT / TOPICAL	AB	2018-06-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210753-001	DIFLORASONE DIACETATE	0.05%	OINTMENT / TOPICAL	AB	2018-06-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210753-001	DIFLORASONE DIACETATE	0.05%	OINTMENT / TOPICAL	AB	2018-06-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210753-001	DIFLORASONE DIACETATE	0.05%	OINTMENT / TOPICAL	AB	2018-06-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210753-001	DIFLORASONE DIACETATE	0.05%	OINTMENT / TOPICAL	AB	2018-06-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210753-001	DIFLORASONE DIACETATE	0.05%	OINTMENT / TOPICAL	AB	2018-06-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210753-001	DIFLORASONE DIACETATE	0.05%	OINTMENT / TOPICAL	AB	2018-06-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210753-001	DIFLORASONE DIACETATE	0.05%	OINTMENT / TOPICAL	AB	2018-06-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210753-001	DIFLORASONE DIACETATE	0.05%	OINTMENT / TOPICAL	AB	2018-06-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210753-001	DIFLORASONE DIACETATE	0.05%	OINTMENT / TOPICAL	AB	2018-06-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210753-001	DIFLORASONE DIACETATE	0.05%	OINTMENT / TOPICAL	AB	2018-06-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210753-001	DIFLORASONE DIACETATE	0.05%	OINTMENT / TOPICAL	AB	2018-06-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210753-001	DIFLORASONE DIACETATE	0.05%	OINTMENT / TOPICAL	AB	2018-06-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210753-001	DIFLORASONE DIACETATE	0.05%	OINTMENT / TOPICAL	AB	2018-06-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210753-001	DIFLORASONE DIACETATE	0.05%	OINTMENT / TOPICAL	AB	2018-06-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210753-001	DIFLORASONE DIACETATE	0.05%	OINTMENT / TOPICAL	AB	2018-06-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210753-001	DIFLORASONE DIACETATE	0.05%	OINTMENT / TOPICAL	AB	2018-06-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210753-001	DIFLORASONE DIACETATE	0.05%	OINTMENT / TOPICAL	AB	2018-06-12	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A210753-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210753-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210753-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210753-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210753-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210753-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210753-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210753-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210753-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210753-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210753-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210753-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210753-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210753-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210753-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210753-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210753-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210753-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210753-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210753-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210753-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210753-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210753-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210753-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210753-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210753-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210753-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210753-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210753-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210753-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210753-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210753-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210753-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210753-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210753-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210753-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210753-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210753-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210753-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210753-001	AB	1	`cb3db0bc1861…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diflorasone Diacetate	DIFLORASONE DIACETATE	Sun Pharmaceutical Industries, Inc.	b20c9420-8fb4-4a49-93f0-c0e4074d6d71	2025-09-22	Adverse reactions	Name fallback brand name: Diflorasone Diacetate generic name: DIFLORASONE DIACETATE
Diflorasone Diacetate	DIFLORASONE DIACETATE	Sun Pharmaceutical Industries, Inc.	b304dfca-e840-4c03-8217-73aaa5360277	2025-07-03	Adverse reactions	Name fallback brand name: Diflorasone Diacetate generic name: DIFLORASONE DIACETATE
psorcon	DIFLORASONE DIACETATE	Sun Pharmaceutical Industries, Inc.	de40cc65-f955-423f-9cbd-bc2245c4f982	2025-07-02	Adverse reactions	Name fallback generic name: DIFLORASONE DIACETATE
Diflorasone Diacetate	DIFLORASONE DIACETATE	Rising Pharma Holdings, Inc.	23eb27a4-157f-4eb5-a390-37586710808f	2023-05-02	Adverse reactions	Name fallback brand name: Diflorasone Diacetate generic name: DIFLORASONE DIACETATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52565-063	Diflorasone Diacetate	Diflorasone Diacetate	Teligent Pharma, Inc.	ANDA	Current
52565-063	Diflorasone Diacetate	Diflorasone Diacetate	Teligent Pharma, Inc.	ANDA	Current
70512-031	Diflorasone Diacetate Oint	Diflorasone Diacetate Ointment	Sola Pharmaceuticals	ANDA	Current
70512-031	Diflorasone Diacetate Oint	Diflorasone Diacetate Ointment	Sola Pharmaceuticals	ANDA	Current
70512-031	Diflorasone Diacetate Oint	Diflorasone Diacetate Ointment	Sola Pharmaceuticals	ANDA	Current