Application 215933

Type: ANDA
Sponsor: SENTISS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LOTEPREDNOL ETABONATE	LOTEPREDNOL ETABONATE	SUSPENSION/DROPS;OPHTHALMIC	0.2%	No	No

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
A215933-001	LOTEPREDNOL ETABONATE	LOTEPREDNOL ETABONATE	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB		2023-04-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215933-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A215933-001	LOTEPREDNOL ETABONATE	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	2023-04-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215933-001	LOTEPREDNOL ETABONATE	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	2023-04-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215933-001	LOTEPREDNOL ETABONATE	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	2023-04-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215933-001	LOTEPREDNOL ETABONATE	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	2023-04-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215933-001	LOTEPREDNOL ETABONATE	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	2023-04-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215933-001	LOTEPREDNOL ETABONATE	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	2023-04-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215933-001	LOTEPREDNOL ETABONATE	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	2023-04-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215933-001	LOTEPREDNOL ETABONATE	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	2023-04-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215933-001	LOTEPREDNOL ETABONATE	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	2023-04-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215933-001	LOTEPREDNOL ETABONATE	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	2023-04-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215933-001	LOTEPREDNOL ETABONATE	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	2023-04-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215933-001	LOTEPREDNOL ETABONATE	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	2023-04-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215933-001	LOTEPREDNOL ETABONATE	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	2023-04-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215933-001	LOTEPREDNOL ETABONATE	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	2023-04-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215933-001	LOTEPREDNOL ETABONATE	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	2023-04-12	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215933-001	LOTEPREDNOL ETABONATE	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	2023-04-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215933-001	LOTEPREDNOL ETABONATE	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	2023-04-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215933-001	LOTEPREDNOL ETABONATE	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	2023-04-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215933-001	LOTEPREDNOL ETABONATE	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	2023-04-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215933-001	LOTEPREDNOL ETABONATE	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	2023-04-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215933-001	LOTEPREDNOL ETABONATE	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	2023-04-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215933-001	LOTEPREDNOL ETABONATE	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	2023-04-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215933-001	LOTEPREDNOL ETABONATE	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	2023-04-12	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215933-001	LOTEPREDNOL ETABONATE	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	2023-04-12	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A215933-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215933-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215933-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215933-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215933-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215933-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215933-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215933-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215933-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215933-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215933-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215933-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215933-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215933-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215933-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215933-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215933-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215933-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215933-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215933-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215933-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215933-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215933-001	AB	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215933-001	AB	1	`a50c72e98297…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loteprednol Etabonate	LOTEPREDNOL ETABONATE	Sentiss Pharmaceuticals LLC	f210d817-409f-4e69-b8d0-58883c0b43d3	2026-04-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215933 application number: ANDA215933
Loteprednol Etabonate	LOTEPREDNOL ETABONATE	Sportpharm LLC	1677e1a2-c598-4341-ab01-927f32e1b856	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215933 application number: ANDA215933
Loteprednol Etabonate	LOTEPREDNOL ETABONATE	ARMAS PHARMACEUTICALS INC.	36c05fa4-6562-4af8-86ac-e79003ee65dd	2024-05-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215933 application number: ANDA215933

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74148	ORIG	2023-05-02