Details for New Drug Application (NDA): 065398
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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 065398
Tradename: | AZITHROMYCIN |
Applicant: | Lupin Ltd |
Ingredient: | azithromycin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 065398
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AZITHROMYCIN | azithromycin | TABLET;ORAL | 065398 | ANDA | Major Pharmaceuticals | 0904-6708 | 0904-6708-06 | 5 BLISTER PACK in 1 CARTON (0904-6708-06) / 10 TABLET in 1 BLISTER PACK |
AZITHROMYCIN | azithromycin | TABLET;ORAL | 065398 | ANDA | Major Pharmaceuticals | 0904-6708 | 0904-6708-61 | 10 BLISTER PACK in 1 CARTON (0904-6708-61) / 10 TABLET in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 250MG BASE | ||||
Approval Date: | May 15, 2015 | TE: | AB | RLD: | No |
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