FDA.reportPublic FDA data

Application 202002

Type
ANDA
Sponsor
STRIDES PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IMIQUIMODIMIQUIMODCREAM;TOPICAL5%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
A202002-001IMIQUIMODIMIQUIMOD5%CREAM / TOPICAL2014-06-24

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 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A202002-001IMIQUIMOD5%CREAM / TOPICAL2014-06-24e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202002-001IMIQUIMOD5%CREAM / TOPICAL2014-06-24cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A202002-001IMIQUIMOD5%CREAM / TOPICAL2014-06-24a50c72e98297…

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ImiquimodIMIQUIMODSun Pharmaceutical Industries, Inc.51913a5a-1cab-4b9e-b2c2-e0174062df732026-01-21Warnings, Adverse reactionsName fallback
brand name: Imiquimod
generic name: IMIQUIMOD
ImiquimodIMIQUIMODBryant Ranch Prepack9291e5cd-b83d-4b43-88f5-30cac6cef5ff2025-11-05Warnings, Adverse reactionsName fallback
brand name: Imiquimod
generic name: IMIQUIMOD
ImiquimodIMIQUIMODBryant Ranch Prepackf8db59e2-8052-413b-9f9f-07cd9eea07ec2025-09-25Warnings, Adverse reactionsName fallback
brand name: Imiquimod
generic name: IMIQUIMOD
ImiquimodIMIQUIMODSun Pharmaceutical Industries, Inc.59af8153-4cf8-4f22-9000-f239798d52d12025-08-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Imiquimod
generic name: IMIQUIMOD
ImiquimodIMIQUIMODBryant Ranch Prepack47d3045f-a145-4095-bb8a-c67ba1ff3bda2025-07-29Warnings, Adverse reactionsName fallback
brand name: Imiquimod
generic name: IMIQUIMOD
ImiquimodIMIQUIMODTeva Pharmaceuticals USA, Inc.9f2cbefd-f295-47e2-8a9e-3e7c5812c9632025-06-30Warnings, Adverse reactionsName fallback
brand name: Imiquimod
generic name: IMIQUIMOD
ImiquimodIMIQUIMODOceanside Pharmacueticalsd86eeb0e-70e0-4c72-aaa3-37daa1d8611e2025-06-03Warnings, Adverse reactionsName fallback
brand name: Imiquimod
generic name: IMIQUIMOD
ZyclaraIMIQUIMODBausch Health US, LLC28cd9b5b-680b-480f-b33d-9c5b52bbf03d2025-05-23Warnings, Adverse reactionsName fallback
generic name: IMIQUIMOD
ImiquimodIMIQUIMODGlenmark Pharmaceuticals Inc., USA663e39a9-a29e-473f-89ec-4c7c6bc27b8a2025-01-23Warnings, Adverse reactionsName fallback
brand name: Imiquimod
generic name: IMIQUIMOD
IMIQUIMODIMIQUIMODDIRECT RXa18a3f7e-7254-56c0-e053-2a95a90a70362025-01-17Warnings, Adverse reactionsName fallback
brand name: IMIQUIMOD
generic name: IMIQUIMOD

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
64380-773imiquimodimiquimodStrides Shasun LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9939ORIG2014-06-26