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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
July 17, 2019
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Erythromycin(500 mg in 1 1)

Products3

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
52536-186
Application Number
ANDA062298
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
July 18, 2019
silicon dioxideInactive
Code: ETJ7Z6XBU4Class: IACT
diacetylated monoglyceridesInactive
Code: 5Z17386USFClass: IACT
Code: 63937KV33DClass: ACTIBQuantity: 500 mg in 1 1
croscarmellose sodiumInactive
Code: M28OL1HH48Class: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MKClass: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
hypromellose, unspecifiedInactive
Code: 3NXW29V3WOClass: IACT
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)Inactive
Code: 87Y6436BKRClass: IACT
propylene glycolInactive
Code: 6DC9Q167V3Class: IACT
microcrystalline celluloseInactive
Code: OP1R32D61UClass: IACT
povidone, unspecifiedInactive
Code: FZ989GH94EClass: IACT
sodium citrate, unspecified formInactive
Code: 1Q73Q2JULRClass: IACT
sorbitan monooleateInactive
Code: 06XEA2VD56Class: IACT
talcInactive
Code: 7SEV7J4R1UClass: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT

Erythromycin

Product Details

NDC Product Code
52536-180
Application Number
ANDA062298
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
July 18, 2019
Code: 63937KV33DClass: ACTIBQuantity: 250 mg in 1 1
silicon dioxideInactive
Code: ETJ7Z6XBU4Class: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48Class: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MKClass: IACT
diacetylated monoglyceridesInactive
Code: 5Z17386USFClass: IACT
hypromellose, unspecifiedInactive
Code: 3NXW29V3WOClass: IACT
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)Inactive
Code: 87Y6436BKRClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
povidone, unspecifiedInactive
Code: FZ989GH94EClass: IACT
sodium citrate, unspecified formInactive
Code: 1Q73Q2JULRClass: IACT
microcrystalline celluloseInactive
Code: OP1R32D61UClass: IACT
propylene glycolInactive
Code: 6DC9Q167V3Class: IACT
sorbitan monooleateInactive
Code: 06XEA2VD56Class: IACT
talcInactive
Code: 7SEV7J4R1UClass: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT

Erythromycin

Product Details

NDC Product Code
52536-183
Application Number
ANDA062298
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
July 18, 2019
Code: 63937KV33DClass: ACTIBQuantity: 333 mg in 1 1
silicon dioxideInactive
Code: ETJ7Z6XBU4Class: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48Class: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MKClass: IACT
diacetylated monoglyceridesInactive
Code: 5Z17386USFClass: IACT
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)Inactive
Code: 87Y6436BKRClass: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
hypromellose, unspecifiedInactive
Code: 3NXW29V3WOClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
propylene glycolInactive
Code: 6DC9Q167V3Class: IACT
sodium citrate, unspecified formInactive
Code: 1Q73Q2JULRClass: IACT
sorbitan monooleateInactive
Code: 06XEA2VD56Class: IACT
microcrystalline celluloseInactive
Code: OP1R32D61UClass: IACT
talcInactive
Code: 7SEV7J4R1UClass: IACT
povidone, unspecifiedInactive
Code: FZ989GH94EClass: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
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