Details for New Drug Application (NDA): 021906
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The generic ingredient in KALETRA is lopinavir; ritonavir. There are thirteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the lopinavir; ritonavir profile page.
Summary for 021906
Tradename: | KALETRA |
Applicant: | Abbvie |
Ingredient: | lopinavir; ritonavir |
Patents: | 0 |
Pharmacology for NDA: 021906
Suppliers and Packaging for NDA: 021906
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
KALETRA | lopinavir; ritonavir | TABLET;ORAL | 021906 | NDA | AbbVie Inc. | 0074-0522 | 0074-0522-60 | 60 TABLET, FILM COATED in 1 BOTTLE (0074-0522-60) |
KALETRA | lopinavir; ritonavir | TABLET;ORAL | 021906 | NDA | AbbVie Inc. | 0074-3008 | 0074-3008-60 | 60 TABLET, FILM COATED in 1 BOTTLE (0074-3008-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG;50MG | ||||
Approval Date: | Oct 28, 2005 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG;25MG | ||||
Approval Date: | Nov 9, 2007 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 021906
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Abbvie | KALETRA | lopinavir; ritonavir | TABLET;ORAL | 021906-002 | Nov 9, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | KALETRA | lopinavir; ritonavir | TABLET;ORAL | 021906-001 | Oct 28, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | KALETRA | lopinavir; ritonavir | TABLET;ORAL | 021906-001 | Oct 28, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | KALETRA | lopinavir; ritonavir | TABLET;ORAL | 021906-001 | Oct 28, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | KALETRA | lopinavir; ritonavir | TABLET;ORAL | 021906-002 | Nov 9, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | KALETRA | lopinavir; ritonavir | TABLET;ORAL | 021906-001 | Oct 28, 2005 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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