DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 203294
The generic ingredient in AZITHROMYCIN is azithromycin. There are thirty-two drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the azithromycin profile page.
Summary for 203294
Tradename: | AZITHROMYCIN |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | azithromycin |
Patents: | 0 |
Therapeutic Class: | Antibacterials |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 203294
Ingredient-type | Macrolides |
Medical Subject Heading (MeSH) Categories for 203294
Suppliers and Packaging for NDA: 203294
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AZITHROMYCIN | azithromycin | INJECTABLE;INJECTION | 203294 | ANDA | AuroMedics Pharma LLC | 55150-174 | N | 55150-174-10 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG BASE/VIAL | ||||
Approval Date: | Jun 19, 2015 | TE: | AP | RLD: | No |
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