DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 065488
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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