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Approved Drug Products containing 21131 listed in the FDA Orange Book. Original Data : FDA Website

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01 PFIZER (3)

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01 SOLUTION;INTRAVENOUS (3)

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01 DISCN (1)

02 RX (2)

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01 ZYVOX (3)

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01 Yes (3)

URL Supplier Web Content
SOLUTION; INTRAVEN...
200MG/100ML (2MG/M...
2000-04-18
21131
ZYVOX
RX
Yes
AP
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URL Supplier Web Content
SOLUTION; INTRAVEN...
400MG/200ML (2MG/M...
2000-04-18
21131
ZYVOX
DISCN
Yes
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SOLUTION; INTRAVEN...
600MG/300ML (2MG/M...
2000-04-18
21131
ZYVOX
RX
Yes
AP
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Looking for FDA Orange Book APPLICATION 21131

Looking for FDA Orange Book APPLICATION 21131 3

19

Pfizer Inc, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is LINEZOLID, with a corresponding application number 21131.

Regulatory Information RX

With a dosage strength 200MG/100ML (2MG/ML)

Dosage Form Route SOLUTION; INTRAVENOUS

Reference Listed Drug Yes

Approved since 2000-04-18

Therapeutic Equivalence (TE) Code AP

18

Pfizer Inc, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is LINEZOLID, with a corresponding application number 21131.

Regulatory Information DISCN

With a dosage strength 400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route SOLUTION; INTRAVENOUS

Reference Listed Drug Yes

Approved since 2000-04-18

17

Pfizer Inc, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is LINEZOLID, with a corresponding application number 21131.

Regulatory Information RX

With a dosage strength 600MG/300ML (2MG/ML)

Dosage Form Route SOLUTION; INTRAVENOUS

Reference Listed Drug Yes

Approved since 2000-04-18

Therapeutic Equivalence (TE) Code AP

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