FDA.reportPublic FDA data

Application 220360

Type
ANDA
Sponsor
MANKIND PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LATANOPROSTLATANOPROSTSOLUTION/DROPS;OPHTHALMIC0.005%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
A220360-001LATANOPROSTLATANOPROST0.005%SOLUTION/DROPS / OPHTHALMIC2025-12-17

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 22:38:342026-08A220360-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMIC2025-12-1784e616aacf4f…
2026-08-18 06:07:402026-07A220360-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMIC2025-12-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A220360-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMICAT2025-12-17011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220360-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMIC2025-12-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A220360-001AT1011fe1cb6892…

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 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LATANOPROSTLATANOPROSTNuCare Pharmaceuticals,Inc.be74d517-7f73-a74c-e053-2a95a90a38192026-09-04Warnings, Adverse reactionsName fallback
brand name: LATANOPROST
generic name: LATANOPROST
LatanoprostLATANOPROSTMicro Labs Limited298fc762-f4d4-47cb-a7a2-b5dc7f965c7f2026-01-21Warnings, Adverse reactionsName fallback
brand name: Latanoprost
generic name: LATANOPROST
LATANOPROSTLATANOPROSTRising Pharma Holdings, Inc.e25b82a9-1b04-4b40-8472-be107a2a67312026-01-02Warnings, Adverse reactionsName fallback
brand name: LATANOPROST
generic name: LATANOPROST
LATANOPROSTLATANOPROSTSomerset Therapeutics, LLC5d0b99ad-f05a-44c7-ac61-26b5a533ea8d2025-12-22Warnings, Adverse reactionsName fallback
brand name: LATANOPROST
generic name: LATANOPROST
XELPROSLATANOPROSTSun Pharmaceutical Industries, Inc.34ad5cf6-4df0-4104-bddd-4c7631133ded2025-12-18Warnings, Adverse reactionsName fallback
generic name: LATANOPROST
latanoprostLATANOPROSTGLENMARK PHARMACEUTICALS INC821d2ad5-a430-4fd2-8cfd-50b2118b86392025-12-18Warnings, Adverse reactionsName fallback
brand name: latanoprost
generic name: LATANOPROST
LatanoprostLATANOPROSTBausch & Lomb Incorporated68aaacbe-98c5-450b-9bf4-4809d7ad2ca02025-10-23Warnings, Adverse reactionsName fallback
brand name: Latanoprost
generic name: LATANOPROST
LatanoprostLATANOPROSTNuCare Pharmaceuticals, Inc.3c47a089-2c72-f58c-e063-6294a90a4cce2025-08-13Warnings, Adverse reactionsName fallback
brand name: Latanoprost
generic name: LATANOPROST
LatanoprostLATANOPROSTSagent Pharmaceuticals7474dc53-e5e5-44f2-9f56-b2cbacdc0c322025-06-26Warnings, Adverse reactionsName fallback
brand name: Latanoprost
generic name: LATANOPROST
LatanoprostLATANOPROSTA-S Medication Solutions5f1987e0-b0ce-47b2-998b-97453a7db5c32025-01-09Warnings, Adverse reactionsName fallback
brand name: Latanoprost
generic name: LATANOPROST
latanoprostLATANOPROSTGland Pharma Limited113abcc6-6e5c-4a57-ad6a-d69508ee990e2024-11-29Warnings, Adverse reactionsName fallback
brand name: latanoprost
generic name: LATANOPROST
LatanoprostLATANOPROSTProficient Rx LPbfd773ed-c461-4732-b1ba-0c240f3fdae02024-10-01Warnings, Adverse reactionsName fallback
brand name: Latanoprost
generic name: LATANOPROST
LatanoprostLATANOPROSTAurobindo Pharma Limited19cdfef0-b770-4758-8f59-1769e4b6119c2024-09-27Warnings, Adverse reactionsName fallback
brand name: Latanoprost
generic name: LATANOPROST
LatanoprostLATANOPROSTMylan Pharmaceuticals Inc.463ecfde-5acb-4983-969d-0c0021bfbf482024-09-15Warnings, Adverse reactionsName fallback
brand name: Latanoprost
generic name: LATANOPROST
LatanoprostLATANOPROSTA-S Medication Solutions8fb5edec-d94a-4aad-b42e-756267a3ae552024-02-27Warnings, Adverse reactionsName fallback
brand name: Latanoprost
generic name: LATANOPROST
XALATANLATANOPROSTViatris Specialty LLCa98595b3-9f47-48e0-b18d-550a2095f2642023-05-15Warnings, Adverse reactionsName fallback
generic name: LATANOPROST
LatanoprostLATANOPROSTSandoz Inc1fba56a6-c8dc-4f34-b05d-efdea75d2fea2023-01-31Warnings, Adverse reactionsName fallback
brand name: Latanoprost
generic name: LATANOPROST

Reported adverse events (FAERS/openFDA)#

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