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FDA Approval

Erythromycin

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

FDA Approval Summary

Company
Effective Date
December 22, 2023
Labeling Type
Human Prescription Drug Label
Erythromycin(500 mg in 1 1)

Manufacturing Establishments1

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

Cadila Pharmaceuticals Limited

Cadila Pharmaceuticals Limited

918451696

Products2

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

Erythromycin

Product Details

NDC Product Code
71209-101
Application Number
ANDA213628
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 22, 2023
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671PClass: IACT
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)Inactive
Code: 87Y6436BKRClass: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
Code: 63937KV33DClass: ACTIBQuantity: 500 mg in 1 1
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808BClass: IACT
SORBIC ACIDInactive
Code: X045WJ989BClass: IACT

Erythromycin

Product Details

NDC Product Code
71209-100
Application Number
ANDA213628
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 22, 2023
D&C RED NO. 30Inactive
Code: 2S42T2808BClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
SORBIC ACIDInactive
Code: X045WJ989BClass: IACT
Code: 63937KV33DClass: ACTIBQuantity: 250 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671PClass: IACT
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)Inactive
Code: 87Y6436BKRClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
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