Details for New Drug Application (NDA): 203564
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NDA 203564 describes LAMIVUDINE, which is a drug marketed by Aurobindo Pharma, Chartwell Molecular, Hetero Labs Ltd Iii, Annora, Apotex, Appco, Aurobindo Pharma Ltd, Aurobindo Pharma Usa, Breckenridge, Cipla, Hetero Labs Ltd V, Lupin Ltd, Macleods Pharms Ltd, Natco, Pharmobedient, Strides Pharma, Chartwell Rx, Epic Pharma Llc, Norvium Bioscience, Pharmacare, and Micro Labs, and is included in thirty-four NDAs. It is available from thirteen 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 203564
| Tradename: | LAMIVUDINE |
| Applicant: | Chartwell Molecular |
| Ingredient: | lamivudine |
| Patents: | 0 |
Pharmacology for NDA: 203564
| Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Medical Subject Heading (MeSH) Categories for 203564
Suppliers and Packaging for NDA: 203564
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LAMIVUDINE | lamivudine | SOLUTION;ORAL | 203564 | ANDA | Chartwell RX, LLC | 62135-706 | 62135-706-24 | 2 TRAY in 1 BOX (62135-706-24) / 10 CUP in 1 TRAY / 30 mL in 1 CUP (62135-706-30) |
| LAMIVUDINE | lamivudine | SOLUTION;ORAL | 203564 | ANDA | Chartwell RX, LLC | 62135-706 | 62135-706-37 | 240 mL in 1 BOTTLE, PLASTIC (62135-706-37) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 10MG/ML | ||||
| Approval Date: | Oct 31, 2014 | TE: | AA | RLD: | No | ||||
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