FDA.reportPublic FDA data

Application 085970

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDETABLET;ORAL150MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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
2019-12-13 00:20 UTC2019-12A085970-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALABApproved before 198274a2ff9319b5…
2019-12-14 00:12 UTC2019-12A085970-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALABApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A085970-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALABApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A085970-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALABApproved before 1982ea99ee380514…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A085970-001AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A085970-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A085970-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A085970-001AB1ea99ee380514…

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
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDESandoz Inc705a2bae-031d-4218-82fe-4346542c0baa2025-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (product): 0781-1491

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 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-1491Amitriptyline HydrochlorideAmitriptyline HydrochlorideSandoz IncANDACurrent
0781-1491Amitriptyline HydrochlorideAmitriptyline HydrochlorideSandoz IncANDACurrent
0781-1491Amitriptyline HydrochlorideAmitriptyline HydrochlorideSandoz IncANDACurrent
0781-1491Amitriptyline HydrochlorideAmitriptyline HydrochlorideSandoz IncANDACurrent
16714-451Amitriptyline HydrochlorideAmitriptyline HydrochlorideNorthstar RxLLCANDACurrent
16714-451Amitriptyline HydrochlorideAmitriptyline HydrochlorideNorthstar RxLLCANDACurrent
16714-451Amitriptyline HydrochlorideAmitriptyline HydrochlorideNorthstar RxLLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39590SUPPL2014-09-05