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FDA Approval

venlafaxine

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Almatica Pharma LLC
DUNS: 962454505
Effective Date
August 24, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Venlafaxine besylate(112.5 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Norwich Pharmaceuticals, Inc.

Almatica Pharma LLC

132218731

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

venlafaxine

Product Details

NDC Product Code
52427-632
Application Number
NDA215429
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
November 19, 2019
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
AMMONIO METHACRYLATE COPOLYMER TYPE AInactive
Code: 8GQS4E66YYClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Code: 18XP3YT5NHClass: ACTIMQuantity: 112.5 mg in 1 1
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