FDA.reportPublic FDA data

Application 075282

Type
ANDA
Sponsor
SANDOZ 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 44.

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
A075282-001CROMOLYN SODIUMCROMOLYN SODIUM4%SOLUTION/DROPS / OPHTHALMICRS1999-06-16

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A075282-001CROMOLYN SODIUM4%SOLUTION/DROPS / OPHTHALMICAT1999-06-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075282-001CROMOLYN SODIUM4%SOLUTION/DROPS / OPHTHALMICAT1999-06-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075282-001CROMOLYN SODIUM4%SOLUTION/DROPS / OPHTHALMICAT1999-06-16cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A075282-001CROMOLYN SODIUM4%SOLUTION/DROPS / OPHTHALMICRS1999-06-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075282-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075282-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075282-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075282-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075282-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075282-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075282-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A075282-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075282-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075282-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075282-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A075282-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075282-001AT1ea99ee380514…
2023-01-26 05:58 UTC2023-01A075282-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075282-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075282-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075282-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075282-001AT1cb3db0bc1861…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cromolyn SodiumCROMOLYN SODIUMPreferred Pharmaceuticals Inc.18892411-465f-4d8d-9550-7dafa6c6a0a32026-04-01Adverse reactionsExact identifier
application applno (ANDA): 075282
application number: ANDA075282
Cromolyn SodiumCROMOLYN SODIUMSandoz Incb32851c3-cd97-4be4-a09c-1deab1d6966b2025-02-20Adverse reactionsExact identifier
application applno (ANDA): 075282
application number: ANDA075282
ndc (product): 61314-237
Cromolyn SodiumCROMOLYN SODIUMA-S Medication Solutions0d30fb0a-e343-426d-8203-5816bd4cec2f2024-11-07Adverse reactionsExact identifier
application applno (ANDA): 075282
application number: ANDA075282
ndc (product): 50090-1202
Cromolyn SodiumCROMOLYN SODIUMProficient Rx LP34ef00e8-0c01-4225-9a40-822ab245752a2019-10-01Adverse reactionsExact identifier
application applno (ANDA): 075282
application number: ANDA075282
ndc (product): 71205-230

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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-1202Cromolyn SodiumCromolyn SodiumA-S Medication SolutionsANDACurrent
50090-1202Cromolyn SodiumCromolyn SodiumA-S Medication SolutionsANDACurrent
50090-1202Cromolyn SodiumCromolyn SodiumA-S Medication SolutionsANDACurrent
50090-1202Cromolyn SodiumCromolyn SodiumA-S Medication SolutionsANDACurrent
53002-0140Cromolyn SodiumCromolyn SodiumRPK Pharmaceuticals, Inc.ANDACurrent
61314-237Cromolyn SodiumCromolyn SodiumSandoz IncANDACurrent
61314-237Cromolyn SodiumCromolyn SodiumSandoz IncANDACurrent
61314-237Cromolyn SodiumCromolyn SodiumSandoz IncANDACurrent
71205-230Cromolyn SodiumCromolyn SodiumProficient Rx LPANDACurrent
71205-230Cromolyn SodiumCromolyn SodiumProficient Rx LPANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8597ORIG1999-06-16