Details for New Drug Application (NDA): 065400
✉ 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 065400
Tradename: | AZITHROMYCIN |
Applicant: | Lupin Ltd |
Ingredient: | azithromycin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 065400
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AZITHROMYCIN | azithromycin | TABLET;ORAL | 065400 | ANDA | American Health Packaging | 60687-314 | 60687-314-25 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-314-25) / 1 TABLET in 1 BLISTER PACK (60687-314-95) |
AZITHROMYCIN | azithromycin | TABLET;ORAL | 065400 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-162 | 68180-162-06 | 30 TABLET in 1 CONTAINER (68180-162-06) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 600MG BASE | ||||
Approval Date: | May 15, 2015 | TE: | AB | RLD: | No |
Complete Access Available with Subscription