FDA.reportPublic FDA data

Application 085032

Type
ANDA
Sponsor
ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDETABLET;ORAL50MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 6 of 6 · 112 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutions00d11130-c9ae-4258-9746-9763bc5deb842023-12-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutions5e8c8c5f-4964-4642-ad4b-69a75b2c8a022023-12-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutionsd22879c5-925a-42e0-9d48-55a4221929832023-12-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEProficient Rx LP6dc9d113-1156-43ec-a7eb-253c2ff6bcfa2023-12-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC25832051-837b-4682-8548-5ab9a1b7cdac2023-11-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC4e0f3b15-3621-48a1-9f2b-b0a3739203602023-09-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEProficient Rx LPe42225f5-44bd-451e-98a1-aa38774577332023-08-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutions1a622039-0a79-407c-8f15-2ea0c58441362023-04-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC8746c047-51b9-4040-aeec-cd1f5b6eb3d42023-03-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutions9440dd10-2f0d-42a7-a037-3ab8729708f62023-01-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: AMITRIPTYLINE HYDROCHLORIDE
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDECentaur Pharmaceuticals Private Limited3d113e43-c694-427f-8b77-66be36a823742022-09-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEProficient Rx LPdf5aee40-ffa9-4cf3-ab5f-30253f43092b2022-05-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: AMITRIPTYLINE HYDROCHLORIDE
generic name: AMITRIPTYLINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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