Details for New Drug Application (NDA): 077695
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NDA 077695 describes LAMIVUDINE, which is a drug marketed by Aurobindo Pharma, Chartwell Molecular, Hetero Labs Ltd Iii, Annora, Apotex, Aurobindo Pharma Ltd, Aurobindo Pharma Usa, Breckenridge, Cipla, Hetero Labs Ltd V, Lupin Ltd, Macleods Pharms Ltd, Mylan Labs Ltd, Natco, Strides Pharma, Upsher Smith Labs, Chartwell Rx, Epic Pharma Llc, Norvium Bioscience, Pharmacare, and Micro Labs, and is included in thirty-four NDAs. It is available from twelve suppliers. Additional details are available on the LAMIVUDINE profile page.
The generic ingredient in LAMIVUDINE is lamivudine; nevirapine; zidovudine. There are twenty-nine drug master file entries for this compound. Additional details are available on the lamivudine; nevirapine; zidovudine profile page.
The generic ingredient in LAMIVUDINE is lamivudine; nevirapine; zidovudine. There are twenty-nine drug master file entries for this compound. Additional details are available on the lamivudine; nevirapine; zidovudine profile page.
Summary for 077695
| Tradename: | LAMIVUDINE |
| Applicant: | Aurobindo Pharma |
| Ingredient: | lamivudine |
| Patents: | 0 |
Pharmacology for NDA: 077695
| Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Medical Subject Heading (MeSH) Categories for 077695
Suppliers and Packaging for NDA: 077695
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LAMIVUDINE | lamivudine | SOLUTION;ORAL | 077695 | ANDA | Rising Pharma Holdings, Inc. | 57237-274 | 57237-274-24 | 240 mL in 1 BOTTLE (57237-274-24) |
| LAMIVUDINE | lamivudine | SOLUTION;ORAL | 077695 | ANDA | Aurobindo Pharma Limited | 65862-055 | 65862-055-24 | 240 mL in 1 BOTTLE (65862-055-24) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 10MG/ML | ||||
| Approval Date: | Nov 21, 2016 | TE: | AA | RLD: | No | ||||
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