Details for New Drug Application (NDA): 208249
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The generic ingredient in AZITHROMYCIN is azithromycin. There are thirty-two drug master file entries for this compound. Sixty-four suppliers are listed for this compound. Additional details are available on the azithromycin profile page.
Summary for 208249
Tradename: | AZITHROMYCIN |
Applicant: | Cspc Ouyi |
Ingredient: | azithromycin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 208249
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AZITHROMYCIN | azithromycin | TABLET;ORAL | 208249 | ANDA | A-S Medication Solutions | 50090-4700 | 50090-4700-0 | 3 CARTON in 1 BOX (50090-4700-0) / 1 TABLET, FILM COATED in 1 CARTON |
AZITHROMYCIN | azithromycin | TABLET;ORAL | 208249 | ANDA | TAGI Pharma, Inc. | 51224-122 | 51224-122-03 | 1 BLISTER PACK in 1 CARTON (51224-122-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 500MG BASE | ||||
Approval Date: | Oct 25, 2018 | TE: | AB | RLD: | No |
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