Details for New Drug Application (NDA): 209201
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NDA 209201 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 sixty-three 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-eight 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-eight suppliers are listed for this compound. Additional details are available on the azithromycin profile page.
Summary for 209201
| Tradename: | AZITHROMYCIN |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | azithromycin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 209201
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AZITHROMYCIN | azithromycin | FOR SUSPENSION;ORAL | 209201 | ANDA | Aurobindo Pharma Limited | 59651-007 | 59651-007-15 | 1 BOTTLE in 1 CARTON (59651-007-15) / 15 mL in 1 BOTTLE |
| AZITHROMYCIN | azithromycin | FOR SUSPENSION;ORAL | 209201 | ANDA | Aurobindo Pharma Limited | 59651-008 | 59651-008-15 | 1 BOTTLE in 1 CARTON (59651-008-15) / 15 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 100MG BASE/5ML | ||||
| Approval Date: | Oct 9, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 200MG BASE/5ML | ||||
| Approval Date: | Oct 9, 2018 | TE: | AB | RLD: | No | ||||
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