FDA.reportPublic FDA data

Application 218087

Type
ANDA
Sponsor
LUPIN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LOTEPREDNOL ETABONATELOTEPREDNOL ETABONATEGEL;OPHTHALMIC0.38%NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218087-001LOTEPREDNOL ETABONATELOTEPREDNOL ETABONATE0.38%GEL / OPHTHALMICAB2025-06-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218087-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A218087-001LOTEPREDNOL ETABONATE0.38%GEL / OPHTHALMICAB2025-06-3084e616aacf4f…
2026-08-18 06:07:402026-07A218087-001LOTEPREDNOL ETABONATE0.38%GEL / OPHTHALMICAB2025-06-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218087-001LOTEPREDNOL ETABONATE0.38%GEL / OPHTHALMICAB2025-06-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218087-001LOTEPREDNOL ETABONATE0.38%GEL / OPHTHALMICAB2025-06-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A218087-001LOTEPREDNOL ETABONATE0.38%GEL / OPHTHALMICAB2025-06-306a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218087-001LOTEPREDNOL ETABONATE0.38%GEL / OPHTHALMICAB2025-06-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A218087-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A218087-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218087-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218087-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218087-001AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218087-001AB1a50c72e98297…

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 2 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Loteprednol EtabonateLOTEPREDNOL ETABONATEARMAS PHARMACEUTICALS INC.08a091a8-748f-acc4-e063-6394a90af4bc2023-10-26Warnings, Adverse reactionsName fallback
brand name: Loteprednol Etabonate
generic name: LOTEPREDNOL ETABONATE
Loteprednol EtabonateLOTEPREDNOL ETABONATEARMAS PHARMACEUTICALS INC.091a068f-f9b0-b02b-e063-6294a90a95e62023-10-25Warnings, Adverse reactionsName fallback
brand name: Loteprednol Etabonate
generic name: LOTEPREDNOL ETABONATE
LOTEMAXLOTEPREDNOL ETABONATEBausch & Lomb Incorporatedf37d74ac-5f9c-40a8-b43b-35148fc66bbe2023-04-17Warnings, Adverse reactionsName fallback
generic name: LOTEPREDNOL ETABONATE
LotemaxLOTEPREDNOL ETABONATEBausch & Lomb Incorporated902a3c6b-2625-44ec-a077-926e012b31762022-11-30Warnings, Adverse reactionsName fallback
generic name: LOTEPREDNOL ETABONATE
AlrexLOTEPREDNOL ETABONATEBausch & Lomb Incorporated21c76da0-50a1-41c0-91b8-8cc4dcc27f602022-03-31Warnings, Adverse reactionsName fallback
generic name: LOTEPREDNOL ETABONATE
Loteprednol EtabonateLOTEPREDNOL ETABONATEBausch & Lomb Incorporated7bbdbd31-5a8f-4d69-aa8e-5b700895e8042021-03-31Warnings, Adverse reactionsName fallback
brand name: Loteprednol Etabonate
generic name: LOTEPREDNOL ETABONATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81319ORIG 2025-02-24