DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 065488
NDA 065488 describes AZITHROMYCIN, which is a drug marketed by Epic Pharma Llc, Lupin Ltd, Pliva, Sandoz, Teva Pharms, Aurobindo Pharma Ltd, Cspc Ouyi Pharm Co, Fresenius Kabi Usa, Gland Pharma Ltd, Hospira, Mylan Asi, Mylan Labs Ltd, Sun Pharm Inds Ltd, Teva Parenteral, Apotex Corp, Mylan, Teva, and Wockhardt, and is included in thirty-six NDAs. It is available from fifty-two 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. Fifty-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. Fifty-eight suppliers are listed for this compound. Additional details are available on the azithromycin profile page.
Summary for 065488
| Tradename: | AZITHROMYCIN |
| Applicant: | Lupin Ltd |
| Ingredient: | azithromycin |
| Patents: | 0 |
| Therapeutic Class: | Antibacterials |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 065488
| Ingredient-type | Macrolides |
Medical Subject Heading (MeSH) Categories for 065488
Suppliers and Packaging for NDA: 065488
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AZITHROMYCIN | azithromycin | FOR SUSPENSION;ORAL | 065488 | ANDA | Lupin Pharmaceuticals,Inc. | 43386-470 | N | 43386-470-60 |
| AZITHROMYCIN | azithromycin | FOR SUSPENSION;ORAL | 065488 | ANDA | Lupin Pharmaceuticals,Inc. | 43386-471 | N | 43386-471-61 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 100MG BASE/5ML | ||||
| Approval Date: | May 15, 2015 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Mar 26, 2018 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 200MG BASE/5ML | ||||
| Approval Date: | May 15, 2015 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Mar 26, 2018 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
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