Details for New Drug Application (NDA): 090923
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NDA 090923 describes AZITHROMYCIN, which is a drug marketed by Amneal, Aurobindo Pharma Ltd, Chartwell Rx, Epic Pharma Llc, Hainan Poly, Pliva, Sandoz, Taro, Teva Pharms, Zydus Lifesciences, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Norvium Bioscience, Rising, Slate Run Pharma, Sun Pharm Inds Ltd, Teva Parenteral, Alembic, Apotex Corp, Aurobindo Pharma Usa, Bionpharma, Cspc Ouyi, Lupin Ltd, Pharmobedient, Strides Pharma, Sunshine, Teva, Yung Shin Pharm, and Zydus Pharms, and is included in sixty-three NDAs. It is available from fifty-seven 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. Sixty-one 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. Sixty-one suppliers are listed for this compound. Additional details are available on the azithromycin profile page.
Summary for 090923
| Tradename: | AZITHROMYCIN |
| Applicant: | Sun Pharm Inds Ltd |
| Ingredient: | azithromycin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 090923
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AZITHROMYCIN | azithromycin | INJECTABLE;INJECTION | 090923 | ANDA | Sun Pharmaceutical Industries, Inc. | 62756-512 | 62756-512-44 | 10 VIAL in 1 PACKAGE (62756-512-44) / 5 mL in 1 VIAL (62756-512-40) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG BASE/VIAL | ||||
| Approval Date: | Apr 2, 2013 | TE: | RLD: | No | |||||
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