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FDA Approval

Amoxicillin

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

FDA Approval Summary

Company
Effective Date
October 5, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Amoxicillin(250 mg in 1 1)

Manufacturing Establishments1

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

A-S Medication Solutions

A-S Medication Solutions

830016429

Products3

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

Amoxicillin

Product Details

NDC Product Code
50090-0455
Application Number
ANDA064013
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
June 7, 2023
Code: 804826J2HUClass: ACTIMQuantity: 250 mg in 1 1
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULRClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT

Amoxicillin

Product Details

NDC Product Code
50090-3005
Application Number
ANDA061931
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
June 7, 2023
Code: 804826J2HUClass: ACTIMQuantity: 125 mg in 5 mL
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULRClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT

Amoxicillin

Product Details

NDC Product Code
50090-1814
Application Number
ANDA061931
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
June 7, 2023
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
Code: 804826J2HUClass: ACTIMQuantity: 250 mg in 5 mL
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULRClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT
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