DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 203294
NDA 203294 describes AZITHROMYCIN, which is a drug marketed by Epic Pharma Llc, Lupin Ltd, Pliva, Sandoz, Teva Pharms, Aurobindo Pharma Ltd, Cspc Ouyi Pharm Co, Fresenius Kabi Usa, Gland Pharma Ltd, Hospira, Mylan Asi, Mylan Labs Ltd, Sun Pharm Inds Ltd, Teva Parenteral, Apotex Corp, Mylan, Teva, and Wockhardt, and is included in thirty-six NDAs. It is available from forty suppliers. Additional details are available on the AZITHROMYCIN profile page.
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.
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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