Details for New Drug Application (NDA): 065400
NDA 065400 describes AZITHROMYCIN, which is a drug marketed by Amneal, Aurobindo Pharma Ltd, Chartwell Rx, Epic Pharma Llc, Pliva, Sandoz, Taro, Teva Pharms, Zhejiang Poly Pharm, Zydus Lifesciences, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hainan Poly, Hikma, Hospira, Pharmobedient, Rising, Sun Pharm Inds Ltd, Teva Parenteral, Alembic, Apotex Corp, Aurobindo Pharma Usa, Bionpharma, Carlsbad, Cspc Ouyi, Extrovis, Fosun Pharma, Lupin, Strides Pharma, Sunshine, Teva, and Zydus Pharms, and is included in sixty-three NDAs. It is available from fifty-five suppliers. Additional details are available on the AZITHROMYCIN profile page.
The generic ingredient in AZITHROMYCIN is azithromycin. There is one drug master file entry for this compound. Fifty-seven suppliers are listed for this compound. Additional details are available on the azithromycin profile page.
The generic ingredient in AZITHROMYCIN is azithromycin. There is one drug master file entry for this compound. Fifty-seven suppliers are listed for this compound. Additional details are available on the azithromycin profile page.
Summary for 065400
| Tradename: | AZITHROMYCIN |
| Applicant: | Lupin |
| Ingredient: | azithromycin |
| Patents: | 0 |
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 | Coupler LLC | 67046-1503 | 67046-1503-3 | 30 TABLET in 1 BLISTER PACK (67046-1503-3) |
| AZITHROMYCIN | azithromycin | TABLET;ORAL | 065400 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-863 | 68180-863-06 | 30 TABLET, FILM COATED in 1 CONTAINER (68180-863-06) |
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 | ||||
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