Details for New Drug Application (NDA): 209201
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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 209201
Tradename: | AZITHROMYCIN |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | azithromycin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 209201
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AZITHROMYCIN | azithromycin | FOR SUSPENSION;ORAL | 209201 | ANDA | Aurobindo Pharma Limited | 59651-007 | 59651-007-15 | 1 BOTTLE in 1 CARTON (59651-007-15) / 15 mL in 1 BOTTLE |
AZITHROMYCIN | azithromycin | FOR SUSPENSION;ORAL | 209201 | ANDA | Aurobindo Pharma Limited | 59651-008 | 59651-008-15 | 1 BOTTLE in 1 CARTON (59651-008-15) / 15 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 100MG BASE/5ML | ||||
Approval Date: | Oct 9, 2018 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 200MG BASE/5ML | ||||
Approval Date: | Oct 9, 2018 | TE: | AB | RLD: | No |
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