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FDA Drug information

Azithromycin

Read time: 1 mins
Marketing start date: 18 Nov 2024
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Summary of product characteristics


Effective Time

20221101

Version

4

Spl Product Data Elements

Azithromycin Azithromycin AZITHROMYCIN DIHYDRATE AZITHROMYCIN ANHYDROUS FD&C RED NO. 40 HYDROXYPROPYL CELLULOSE (90000 WAMW) MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS SUCROSE XANTHAN GUM WHITE TO LIGHT PINK CHERRY RIPE BANANA Azithromycin Azithromycin AZITHROMYCIN DIHYDRATE AZITHROMYCIN ANHYDROUS FD&C RED NO. 40 HYDROXYPROPYL CELLULOSE (90000 WAMW) MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS SUCROSE XANTHAN GUM WHITE TO LIGHT PINK CHERRY RIPE BANANA Azithromycin Azithromycin AZITHROMYCIN DIHYDRATE AZITHROMYCIN ANHYDROUS FD&C RED NO. 40 HYDROXYPROPYL CELLULOSE (90000 WAMW) MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS SUCROSE XANTHAN GUM WHITE TO LIGHT PINK CHERRY RIPE BANANA Azithromycin Azithromycin AZITHROMYCIN DIHYDRATE AZITHROMYCIN ANHYDROUS FD&C RED NO. 40 HYDROXYPROPYL CELLULOSE (90000 WAMW) MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS SUCROSE XANTHAN GUM WHITE TO LIGHT PINK CHERRY RIPE BANANA

Application Number

ANDA211147

Brand Name

Azithromycin

Generic Name

Azithromycin

Product Ndc

70771-1425

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1422-1 Azithromycin for oral suspension, 300 mg 100 mg/5 mL Rx only NDC 70771-1423-2 Azithromycin for oral suspension, 600 mg 200 mg/5 mL Rx only NDC 70771-1424-2 Azithromycin for oral suspension, 900 mg 200 mg/5 mL Rx only NDC 70771-1425-2 Azithromycin for oral suspension, 1200 mg 200 mg/5 mL Rx only Azithromycin oral suspension Azithromycin oral suspension Azithromycin oral suspension Azithromycin oral suspension

Drug section

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