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Approved Drug Products containing 21316 listed in the FDA Orange Book. Original Data : FDA Website

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01 COVIS (4)

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01 TABLET, EXTENDED RELEASE;ORAL (4)

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01 DISCN (1)

02 RX (3)

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01 ALTOPREV (4)

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01 No (1)

02 Yes (3)

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TABLET, EXTENDED R...
60MG
2002-06-26
21316
ALTOPREV
RX
Yes
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TABLET, EXTENDED R...
20MG
2002-06-26
21316
ALTOPREV
RX
Yes
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TABLET, EXTENDED R...
40MG
2002-06-26
21316
ALTOPREV
RX
Yes
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TABLET, EXTENDED R...
10MG
2002-06-26
21316
ALTOPREV
DISCN
No
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Looking for FDA Orange Book APPLICATION 21316

Looking for FDA Orange Book APPLICATION 21316 4

19

Covis Pharma, based in Luxembourg, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is LOVASTATIN, with a corresponding application number 21316.

Regulatory Information RX

With a dosage strength 60MG

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2002-06-26

18

Covis Pharma, based in Luxembourg, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is LOVASTATIN, with a corresponding application number 21316.

Regulatory Information RX

With a dosage strength 20MG

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2002-06-26

17

Covis Pharma, based in Luxembourg, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is LOVASTATIN, with a corresponding application number 21316.

Regulatory Information RX

With a dosage strength 40MG

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2002-06-26

16

Covis Pharma, based in Luxembourg, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is LOVASTATIN, with a corresponding application number 21316.

Regulatory Information DISCN

With a dosage strength 10MG

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug No

Approved since 2002-06-26

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