Details for New Drug Application (NDA): 207531
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NDA 207531 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, Hikma, Hospira, Pharmobedient, Rising, Slate Run Pharma, Sun Pharm Inds Ltd, Teva Parenteral, Alembic, Apotex Corp, Aurobindo Pharma Usa, Bionpharma, Cspc Ouyi, Extrovis, Lupin Ltd, Strides Pharma, Sunshine, Teva, Yung Shin Pharm, and Zydus Pharms, and is included in sixty-three NDAs. It is available from fifty-nine 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 207531
| Tradename: | AZITHROMYCIN |
| Applicant: | Epic Pharma Llc |
| Ingredient: | azithromycin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 207531
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AZITHROMYCIN | azithromycin | FOR SUSPENSION;ORAL | 207531 | ANDA | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 24658-706 | 24658-706-32 | 15 mL in 1 BOTTLE, PLASTIC (24658-706-32) |
| AZITHROMYCIN | azithromycin | FOR SUSPENSION;ORAL | 207531 | ANDA | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 24658-707 | 24658-707-33 | 22.5 mL in 1 BOTTLE, PLASTIC (24658-707-33) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 100MG BASE/5ML | ||||
| Approval Date: | Apr 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: | Apr 9, 2018 | TE: | AB | RLD: | No | ||||
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