Details for New Drug Application (NDA): 077558
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NDA 077558 describes LAMIVUDINE AND ZIDOVUDINE, which is a drug marketed by Aurobindo Pharma, Aurobindo Pharma Ltd, Chartwell Rx, Cipla, Epic Pharma Llc, Hetero Labs Ltd Iii, Hetero Labs Ltd V, Lupin Ltd, Macleods Pharms Ltd, Natco, Norvium Bioscience, Pharmacare, and Strides Pharma, and is included in thirteen NDAs. It is available from eight suppliers. Additional details are available on the LAMIVUDINE AND ZIDOVUDINE profile page.
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.
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 077558
| Tradename: | LAMIVUDINE AND ZIDOVUDINE |
| Applicant: | Aurobindo Pharma |
| Ingredient: | lamivudine; zidovudine |
| Patents: | 0 |
Pharmacology for NDA: 077558
| Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Suppliers and Packaging for NDA: 077558
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LAMIVUDINE AND ZIDOVUDINE | lamivudine; zidovudine | TABLET;ORAL | 077558 | ANDA | Aurobindo Pharma Limited | 65862-036 | 65862-036-10 | 6 BLISTER PACK in 1 CARTON (65862-036-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK |
| LAMIVUDINE AND ZIDOVUDINE | lamivudine; zidovudine | TABLET;ORAL | 077558 | ANDA | Aurobindo Pharma Limited | 65862-036 | 65862-036-60 | 60 TABLET, FILM COATED in 1 BOTTLE (65862-036-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG;300MG | ||||
| Approval Date: | May 5, 2017 | TE: | AB | RLD: | No | ||||
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