FDA.reportPublic FDA data

Application 205367

Type
ANDA
Sponsor
MYLAN PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MILNACIPRAN HYDROCHLORIDEMILNACIPRAN HYDROCHLORIDETABLET;ORAL12.5MGNoNo
002MILNACIPRAN HYDROCHLORIDEMILNACIPRAN HYDROCHLORIDETABLET;ORAL25MGNoNo
003MILNACIPRAN HYDROCHLORIDEMILNACIPRAN HYDROCHLORIDETABLET;ORAL50MGNoNo
004MILNACIPRAN HYDROCHLORIDEMILNACIPRAN HYDROCHLORIDETABLET;ORAL100MGNoNo

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 1 ยท 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Milnacipran HydrochlorideMILNACIPRAN HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.e39b4890-99e4-4e48-9f45-978d5ac9f4022026-07-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Milnacipran Hydrochloride
generic name: MILNACIPRAN HYDROCHLORIDE
Milnacipran HydrochlorideMILNACIPRAN HYDROCHLORIDEGlenmark Pharmaceuticals Inc., USAb66b1850-0d2a-41d6-b0ad-c676166394c72026-03-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Milnacipran Hydrochloride
generic name: MILNACIPRAN HYDROCHLORIDE
MILNACIPRAN HYDROCHLORIDEMILNACIPRAN HYDROCHLORIDECamber Pharmaceuticals, Inc.99efa59a-8458-4e04-8cb1-20abfc1792282026-03-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: MILNACIPRAN HYDROCHLORIDE
generic name: MILNACIPRAN HYDROCHLORIDE
SavellaMILNACIPRAN HYDROCHLORIDECardinal Health 107, LLC8b720a1e-034b-4583-b80d-105a794cce742026-01-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MILNACIPRAN HYDROCHLORIDE
SavellaMILNACIPRAN HYDROCHLORIDEAllergan, Inc.16a4a314-f97e-4e91-95e9-576a3773d2842025-09-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MILNACIPRAN HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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