Details for New Drug Application (NDA): 065501
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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 065501
Tradename: | AZITHROMYCIN |
Applicant: | Gland Pharma Ltd |
Ingredient: | azithromycin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 065501
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AZITHROMYCIN | azithromycin | INJECTABLE;INJECTION | 065501 | ANDA | Gland Pharma Limited | 68083-199 | 68083-199-10 | 10 VIAL in 1 CARTON (68083-199-10) / 10 mL in 1 VIAL |
AZITHROMYCIN | azithromycin | INJECTABLE;INJECTION | 065501 | ANDA | Sun Pharmaceutical Industries Limited | 70095-025 | 70095-025-02 | 10 VIAL in 1 CARTON (70095-025-02) / 10 mL in 1 VIAL (70095-025-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG BASE/VIAL | ||||
Approval Date: | Nov 9, 2009 | TE: | AP | RLD: | No |
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