FDA.reportPublic FDA data

Application 014685

Type
NDA
Sponsor
RANBAXY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AVENTYLNORTRIPTYLINE HYDROCHLORIDESOLUTION;ORALEQ 10MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N014685-001AVENTYLNORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD, Approved before 1982

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09N014685-001AVENTYLEQ 10MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N014685-001AVENTYLEQ 10MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N014685-001AVENTYLEQ 10MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD, Approved before 1982a50c72e98297…

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 3 · 54 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.4852a754-2fc1-4c10-a414-dc8a1dfd66a22026-09-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.c7cce83f-9508-49de-a442-246ad18ddeda2026-08-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEBryant Ranch Prepackcb4d1a69-60ae-4fdc-8af8-059959cf72652026-08-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.f684e9c8-eca7-4e27-872d-c0adea19de9a2026-08-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c282026-07-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEProficient Rx LP1e32f284-a5b2-4ebf-9d9e-0e9a40b46ade2026-07-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDESt. Mary's Medical Park Pharmacy3c57301f-5128-295e-e063-6394a90ad99e2026-06-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.dd1f4d6f-14cc-44c0-b9d3-bb3d17b557fa2026-06-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.522d0cd8-d84d-4961-a525-4527fce44c3c2026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.27e96d6c-b311-45d2-b879-65c6a4efcfba2026-06-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACY21770082-7a99-520d-e063-6394a90ab9cb2026-05-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEA-S Medication Solutionsa2cf7783-7019-49ea-ab55-796674d945462026-03-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEBryant Ranch Prepack8eef261f-5c78-a88f-37c4-46e6b0e0f0ee2026-03-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDECoupler LLC4c21abdb-f3e9-9037-e063-6294a90af4b42026-03-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma3fcabf90-357a-4a06-b680-9572dc28bcfe2026-01-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NORTRIPTYLINE HYDROCHLORIDE
NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDEDirect Rx017f7717-e160-4142-9a5a-1a2bd97767072026-01-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEAdvagen Pharma Ltdbef9e24d-e730-4801-ab25-75e7d6bde2252026-01-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDENorthwind Health Company, LLCdae3314f-3128-787f-e053-2995a90aff192026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDENorthwind Health Company, LLC09a54dbd-6bde-3083-e063-6394a90a52972025-12-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEA-S Medication Solutions686d15d0-6434-42ec-8c78-f45d617d294c2025-12-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NORTRIPTYLINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
12069SUPPL2007-07-31
10846SUPPL2007-07-31
44005ORIG2007-05-09
12068SUPPL2005-01-13
10845SUPPL2005-01-13