Details for New Drug Application (NDA): 209044
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The generic ingredient in AZITHROMYCIN is azithromycin. There are thirty-two drug master file entries for this compound. Sixty-one suppliers are listed for this compound. Additional details are available on the azithromycin profile page.
Summary for 209044
Tradename: | AZITHROMYCIN |
Applicant: | Sunshine |
Ingredient: | azithromycin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 209044
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AZITHROMYCIN | azithromycin | TABLET;ORAL | 209044 | ANDA | Lannett Company, Inc. | 0527-2395 | 0527-2395-19 | 1 BLISTER PACK in 1 CARTON (0527-2395-19) / 3 TABLET, FILM COATED in 1 BLISTER PACK |
AZITHROMYCIN | azithromycin | TABLET;ORAL | 209044 | ANDA | Lannett Company, Inc. | 0527-2395 | 0527-2395-32 | 30 TABLET, FILM COATED in 1 BOTTLE (0527-2395-32) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 500MG BASE | ||||
Approval Date: | Dec 7, 2018 | TE: | AB | RLD: | No |
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