Details for New Drug Application (NDA): 079128
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The generic ingredient in LAMIVUDINE AND ZIDOVUDINE is lamivudine; zidovudine. There are twenty-nine drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the lamivudine; zidovudine profile page.
Summary for 079128
Tradename: | LAMIVUDINE AND ZIDOVUDINE |
Applicant: | Strides Pharma |
Ingredient: | lamivudine; zidovudine |
Patents: | 0 |
Pharmacology for NDA: 079128
Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Suppliers and Packaging for NDA: 079128
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LAMIVUDINE AND ZIDOVUDINE | lamivudine; zidovudine | TABLET;ORAL | 079128 | ANDA | Strides Pharma Science Limited | 64380-707 | 64380-707-03 | 60 TABLET in 1 BOTTLE (64380-707-03) |
LAMIVUDINE AND ZIDOVUDINE | lamivudine; zidovudine | TABLET;ORAL | 079128 | ANDA | Bryant Ranch Prepack | 71335-0141 | 71335-0141-1 | 6 TABLET in 1 BOTTLE (71335-0141-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG;300MG | ||||
Approval Date: | May 13, 2015 | TE: | AB | RLD: | No |
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