Details for New Drug Application (NDA): 207370
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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 207370
Tradename: | AZITHROMYCIN |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | azithromycin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 207370
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AZITHROMYCIN | azithromycin | TABLET;ORAL | 207370 | ANDA | A-S Medication Solutions | 50090-4720 | 50090-4720-0 | 1 BLISTER PACK in 1 CARTON (50090-4720-0) / 6 TABLET, FILM COATED in 1 BLISTER PACK |
AZITHROMYCIN | azithromycin | TABLET;ORAL | 207370 | ANDA | A-S Medication Solutions | 50090-4720 | 50090-4720-1 | 2 BLISTER PACK in 1 CARTON (50090-4720-1) / 6 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 250MG BASE | ||||
Approval Date: | Jul 5, 2018 | TE: | AB | RLD: | No |
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