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 1 of 6 · 112 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.61b29703-cfc2-45c7-ae24-7bf3b77e85872026-09-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.e0aa02a9-3e2d-44c5-a6b9-843c801022492026-09-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.4e520c63-1cf6-40f6-a51c-3f9b0e1813422026-09-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.c072c1b3-ed8a-4f1e-ba6c-580a2b2c8f582026-09-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.bb02d7b8-8f1a-4cc4-b763-223e6894f02c2026-08-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.4132f91e-6f24-476a-9028-bab86ad0598e2026-08-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.5dc3c2d7-60a2-4754-be33-1f9401c925a42026-08-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDECoupler LLC598f6ffb-45c3-3cfc-e063-6294a90a56d12026-08-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDECoupler LLC598f900c-552b-5653-e063-6294a90aff532026-08-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutionse0d5b1f6-c1f2-4d5b-a1c3-aebe77843df22026-08-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.abf6a3f5-0df9-4b23-995d-63b973ef80c12026-08-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.c66e9088-4f34-4b97-971e-5272b45cfc972026-08-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDENorthwind Health Company, LLC471b99ac-395c-3137-e063-6394a90af18d2026-07-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDESt. Mary's Medical Park Pharmacy35aa7ab3-321a-97f7-e063-6294a90a91e22026-06-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEBryant Ranch Prepack16364b31-4b8b-481a-a553-e8974c0e557c2026-06-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDESt. Mary's Medical Park Pharmacye3dd745a-57f5-4925-e053-2995a90a43c02026-06-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.9ced0126-d597-48fb-96d3-5773337600482026-06-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDESt. Mary's Medical Park Pharmacy1b2d2bb8-78c8-7e8e-e063-6294a90a25762026-06-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.ce87013b-bf4a-47d1-9808-7cb8290feb232026-05-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDECoupler LLC5070fa18-ecc9-de14-e063-6394a90a372e2026-04-27Boxed 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.