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FDA Approval

E.E.S

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

FDA Approval Summary

Effective Date
December 16, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Erythromycin(200 mg in 5 mL)

Products3

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

E.E.S

Product Details

NDC Product Code
24338-134
Application Number
NDA050207
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
December 16, 2023
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
MAGNESIUM ALUMINUM SILICATEInactive
Code: 6M3P64V0NCClass: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQYClass: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULRClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
Code: 1014KSJ86FClass: ACTIMQuantity: 200 mg in 5 mL
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311Class: IACT

E.E.S

Product Details

NDC Product Code
24338-136
Application Number
NDA050207
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
December 16, 2023
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQYClass: IACT
MAGNESIUM ALUMINUM SILICATEInactive
Code: 6M3P64V0NCClass: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311Class: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULRClass: IACT
Code: 1014KSJ86FClass: ACTIMQuantity: 200 mg in 5 mL
SUCROSEInactive
Code: C151H8M554Class: IACT

E.E.S 400

Product Details

NDC Product Code
24338-100
Application Number
ANDA061905
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 16, 2023
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808BClass: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULRClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
GLYCERYL MONOCAPRYLOCAPRATEInactive
Code: G7515SW10NClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQUClass: IACT
Code: 1014KSJ86FClass: ACTIMQuantity: 400 mg in 1 1
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