FDA.reportPublic FDA data

Application 075615

Type
ANDA
Sponsor
APOTEX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CROMOLYN SODIUMCROMOLYN SODIUMSOLUTION/DROPS;OPHTHALMIC4%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
A075615-001CROMOLYN SODIUMCROMOLYN SODIUM4%SOLUTION/DROPS / OPHTHALMIC2001-01-26

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 UTC2022-09A075615-001CROMOLYN SODIUM4%SOLUTION/DROPS / OPHTHALMIC2001-01-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075615-001CROMOLYN SODIUM4%SOLUTION/DROPS / OPHTHALMIC2001-01-26cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A075615-001CROMOLYN SODIUM4%SOLUTION/DROPS / OPHTHALMIC2001-01-26a50c72e98297…

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NasalCromCROMOLYN SODIUMPrestige Brands Holdings, Inc.b34d36ca-4df4-458c-af0f-c0d0c9a025d92026-06-03WarningsName fallback
generic name: CROMOLYN SODIUM
Cromolyn SodiumCROMOLYN SODIUMPreferred Pharmaceuticals Inc.18892411-465f-4d8d-9550-7dafa6c6a0a32026-04-01Adverse reactionsName fallback
brand name: Cromolyn Sodium
generic name: CROMOLYN SODIUM
CROMOLYN SODIUMCROMOLYN SODIUMOmnivium Pharmaceuticals LLCa742664b-265e-49f9-9744-d04e1fb620ae2026-01-13Warnings, Adverse reactionsName fallback
brand name: CROMOLYN SODIUM
generic name: CROMOLYN SODIUM
Cromolyn SodiumCROMOLYN SODIUMSandoz Incb32851c3-cd97-4be4-a09c-1deab1d6966b2025-02-20Adverse reactionsName fallback
brand name: Cromolyn Sodium
generic name: CROMOLYN SODIUM
Cromolyn SodiumCROMOLYN SODIUMA-S Medication Solutions0d30fb0a-e343-426d-8203-5816bd4cec2f2024-11-07Adverse reactionsName fallback
brand name: Cromolyn Sodium
generic name: CROMOLYN SODIUM
CROMOLYN SODIUMCROMOLYN SODIUMMicro Labs Limited93f80edb-3b38-423e-8cd6-5b5cb4393ec22024-09-26Warnings, Adverse reactionsName fallback
brand name: CROMOLYN SODIUM
generic name: CROMOLYN SODIUM
GastrocromCROMOLYN SODIUMViatris Specialty LLC00623958-a8fe-47d1-a0d2-0aa4e2f7966e2024-06-26Warnings, Adverse reactionsName fallback
generic name: CROMOLYN SODIUM
Cromolyn SodiumCROMOLYN SODIUMTeva Pharmaceuticals USA, Inc.8fe37a7a-edd6-4733-bb7e-e01c1906aeba2023-12-14Warnings, Adverse reactionsName fallback
brand name: Cromolyn Sodium
generic name: CROMOLYN SODIUM
CROMOLYN SODIUMCROMOLYN SODIUMRising Pharma Holdings, Inc.61c9cb85-129e-4490-b5f7-357307fcecbf2021-08-01Warnings, Adverse reactionsName fallback
brand name: CROMOLYN SODIUM
generic name: CROMOLYN SODIUM
Cromolyn SodiumCROMOLYN SODIUMBausch & Lomb Incorporated379f4b59-6866-4b5c-9b1b-d8a35b7414612021-06-01WarningsName fallback
brand name: Cromolyn Sodium
generic name: CROMOLYN SODIUM
Cromolyn SodiumCROMOLYN SODIUMProficient Rx LP34ef00e8-0c01-4225-9a40-822ab245752a2019-10-01Adverse reactionsName fallback
brand name: Cromolyn Sodium
generic name: CROMOLYN SODIUM

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30957ORIG2001-01-26