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FDA Approval

Metformin Hydrochloride

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

FDA Approval Summary

Company
Effective Date
November 14, 2018
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Metformin(1000 mg in 1 1)

Products2

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

Metformin Hydrochloride

Product Details

NDC Product Code
0378-6001
Application Number
ANDA200690
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
May 25, 2017
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MetforminActive
Code: 786Z46389EClass: ACTIBQuantity: 1000 mg in 1 1
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
CELLULOSE ACETATEInactive
Code: 3J2P07GVB6Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT

Metformin Hydrochloride

Product Details

NDC Product Code
0378-6002
Application Number
ANDA200690
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
May 25, 2017
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
MetforminActive
Code: 786Z46389EClass: ACTIBQuantity: 500 mg in 1 1
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CELLULOSE ACETATEInactive
Code: 3J2P07GVB6Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
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