Details for New Drug Application (NDA): 077221
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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 077221
Tradename: | LAMIVUDINE |
Applicant: | Cipla |
Ingredient: | lamivudine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 077221
Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Medical Subject Heading (MeSH) Categories for 077221
Suppliers and Packaging for NDA: 077221
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LAMIVUDINE | lamivudine | TABLET;ORAL | 077221 | ANDA | Cipla USA Inc. | 69097-166 | 69097-166-03 | 60 TABLET in 1 BOTTLE (69097-166-03) |
LAMIVUDINE | lamivudine | TABLET;ORAL | 077221 | ANDA | Cipla USA Inc. | 69097-167 | 69097-167-02 | 30 TABLET in 1 BOTTLE (69097-167-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
Approval Date: | Mar 3, 2017 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
Approval Date: | Mar 3, 2017 | TE: | AB | RLD: | No |
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