Details for New Drug Application (NDA): 208250
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NDA 208250 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, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Mylan Asi, Rising, Slate Run Pharma, Sun Pharm Inds Ltd, Teva Parenteral, ACI, Alembic, Apotex Corp, Aurobindo Pharma Usa, Bionpharma, Cspc Ouyi, Lupin Ltd, Mylan, 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-two 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-two suppliers are listed for this compound. Additional details are available on the azithromycin profile page.
Summary for 208250
| Tradename: | AZITHROMYCIN |
| Applicant: | Cspc Ouyi |
| Ingredient: | azithromycin |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 208250
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AZITHROMYCIN | azithromycin | TABLET;ORAL | 208250 | ANDA | Medsource Pharmaceuticals | 45865-131 | 45865-131-06 | 6 TABLET, FILM COATED in 1 BLISTER PACK (45865-131-06) |
| AZITHROMYCIN | azithromycin | TABLET;ORAL | 208250 | ANDA | Medsource Pharmaceuticals | 45865-131 | 45865-131-18 | 18 TABLET, FILM COATED in 1 BLISTER PACK (45865-131-18) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 250MG BASE | ||||
| Approval Date: | Apr 17, 2019 | TE: | AB | RLD: | No | ||||
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