Details for New Drug Application (NDA): 022141
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NDA 022141 describes CIMDUO, which is a drug marketed by Mylan Labs Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the CIMDUO profile page.
The generic ingredient in CIMDUO is lamivudine; tenofovir disoproxil fumarate. There are twenty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lamivudine; tenofovir disoproxil fumarate profile page.
The generic ingredient in CIMDUO is lamivudine; tenofovir disoproxil fumarate. There are twenty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lamivudine; tenofovir disoproxil fumarate profile page.
Summary for 022141
| Tradename: | CIMDUO |
| Applicant: | Mylan Labs Ltd |
| Ingredient: | lamivudine; tenofovir disoproxil fumarate |
| Patents: | 0 |
Pharmacology for NDA: 022141
| Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Suppliers and Packaging for NDA: 022141
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CIMDUO | lamivudine; tenofovir disoproxil fumarate | TABLET;ORAL | 022141 | NDA | Viatris Specialty LLC | 49502-450 | 49502-450-93 | 1 BOTTLE, PLASTIC in 1 CARTON (49502-450-93) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG;300MG | ||||
| Approval Date: | Feb 28, 2018 | TE: | RLD: | Yes | |||||
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