FDA.reportPublic FDA data

Application 090576

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NIZATIDINENIZATIDINESOLUTION;ORAL15MG/MLNoYes

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
A090576-001NIZATIDINENIZATIDINE15MG/MLSOLUTION / ORAL2009-11-18

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 UTC2022-10A090576-001NIZATIDINE15MG/MLSOLUTION / ORAL2009-11-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090576-001NIZATIDINE15MG/MLSOLUTION / ORAL2009-11-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090576-001NIZATIDINE15MG/MLSOLUTION / ORAL2009-11-18cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A090576-001NIZATIDINE15MG/MLSOLUTION / ORAL2009-11-18a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NIZATIDINENIZATIDINEAmneal Pharmaceuticals LLC39e62997-8781-449a-e054-00144ff88e882024-10-23Adverse reactionsExact identifier
application applno (ANDA): 090576
application number: ANDA090576
ndc (product): 60846-301

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
60846-301NIZATIDINENIZATIDINEAmneal Pharmaceuticals LLCANDACurrent
60846-301NIZATIDINENIZATIDINEAmneal Pharmaceuticals LLCANDACurrent
60846-301Nizatidine SolutionNizatidineGemini Laboratories, LLCANDACurrent
60846-301NIZATIDINENIZATIDINEAmneal Pharmaceuticals LLCANDACurrent
60846-301NIZATIDINENIZATIDINEAmneal Pharmaceuticals LLCANDACurrent
65162-659NizatidineNizatidineAmneal Pharmaceuticals LLCANDACurrent
65162-659NizatidineNizatidineAmneal Pharmaceuticals LLCANDACurrent
65162-659NizatidineNizatidineAmneal Pharmaceuticals LLCANDACurrent
65162-659NizatidineNizatidineAmneal Pharmaceuticals LLCANDACurrent
65162-659NizatidineNizatidineAmneal Pharmaceuticals LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18537ORIG2010-08-27
9279ORIG2009-11-20