FDA.reportPublic FDA data

Application 217597

Type
ANDA
Sponsor
ALEMBIC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LOTEPREDNOL ETABONATE AND TOBRAMYCINLOTEPREDNOL ETABONATE; TOBRAMYCINSUSPENSION/DROPS;OPHTHALMIC0.5%;0.3%NoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217597-001LOTEPREDNOL ETABONATE AND TOBRAMYCINLOTEPREDNOL ETABONATE; TOBRAMYCIN0.5%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2025-12-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217597-001AB

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
A217597-001CGT2026-07-14

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
2026-02-19 14:30 UTC2026-02A217597-001LOTEPREDNOL ETABONATE AND TOBRAMYCIN0.5%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2025-12-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217597-001LOTEPREDNOL ETABONATE AND TOBRAMYCIN0.5%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2025-12-1031067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217597-001LOTEPREDNOL ETABONATE AND TOBRAMYCIN0.5%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2025-12-10a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A217597-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217597-001AB131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217597-001AB1a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-02-19 14:30 UTC2026-02A217597-001CGT2026-07-14011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217597-001CGT2026-07-14a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Loteprednol etabonate and TobramycinLOTEPREDNOL ETABONATE AND TOBRAMYCINAlembic Pharmaceuticals Limiteda6d68829-f7b6-4b9b-ad44-110c476099182025-12-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217597
application number: ANDA217597
Loteprednol etabonate and TobramycinLOTEPREDNOL ETABONATE AND TOBRAMYCINAlembic Pharmaceuticals Inc.7c752fac-8ec8-49ab-8570-09d2aabbeef02025-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217597
application number: ANDA217597

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84786ORIG 2026-01-21