Details for New Drug Application (NDA): 207398
✉ Email this page to a colleague
The generic ingredient in AZITHROMYCIN is azithromycin. There are thirty-two drug master file entries for this compound. Sixty-two suppliers are listed for this compound. Additional details are available on the azithromycin profile page.
Summary for 207398
Tradename: | AZITHROMYCIN |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | azithromycin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 207398
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AZITHROMYCIN | azithromycin | TABLET;ORAL | 207398 | ANDA | A-S Medication Solutions | 50090-5366 | 50090-5366-0 | 5 TABLET, FILM COATED in 1 BOTTLE (50090-5366-0) |
AZITHROMYCIN | azithromycin | TABLET;ORAL | 207398 | ANDA | A-S Medication Solutions | 50090-5366 | 50090-5366-1 | 1 TABLET, FILM COATED in 1 BOTTLE (50090-5366-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 500MG BASE | ||||
Approval Date: | Jul 5, 2018 | TE: | AB | RLD: | No |
Complete Access Available with Subscription