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Approved Drug Products containing 211962 listed in the FDA Orange Book. Original Data : FDA Website

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01 XELLIA PHARMS APS (7)

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01 SOLUTION;INTRAVENOUS (7)

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01 RX (7)

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01 VANCOMYCIN HYDROCHLORIDE (7)

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01 Yes (7)

URL Supplier Web Content
SOLUTION; INTRAVEN...
EQ 1.25GM BASE/250...
2020-05-13
211962
VANCOMYCIN HYDROCH...
RX
Yes
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SOLUTION; INTRAVEN...
EQ 2GM BASE/400ML ...
2019-02-15
211962
VANCOMYCIN HYDROCH...
RX
Yes
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SOLUTION; INTRAVEN...
EQ 1GM BASE/200ML ...
2019-02-15
211962
VANCOMYCIN HYDROCH...
RX
Yes
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SOLUTION; INTRAVEN...
EQ 1.75GM BASE/350...
2020-05-13
211962
VANCOMYCIN HYDROCH...
RX
Yes
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SOLUTION; INTRAVEN...
EQ 750MG BASE/150M...
2020-05-13
211962
VANCOMYCIN HYDROCH...
RX
Yes
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SOLUTION; INTRAVEN...
EQ 1.5GM BASE/300M...
2019-02-15
211962
VANCOMYCIN HYDROCH...
RX
Yes
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SOLUTION; INTRAVEN...
EQ 500MG BASE/100M...
2019-02-15
211962
VANCOMYCIN HYDROCH...
RX
Yes
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Looking for FDA Orange Book APPLICATION 211962

Looking for FDA Orange Book APPLICATION 211962 7

19

Xellia Pharmaceuticals ApS, based in Denmark, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is VANCOMYCIN HYDROCHLORIDE, with a corresponding application number 211962.

Regulatory Information RX

With a dosage strength EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)

Dosage Form Route SOLUTION; INTRAVENOUS

Reference Listed Drug Yes

Approved since 2020-05-13

18

Xellia Pharmaceuticals ApS, based in Denmark, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is VANCOMYCIN HYDROCHLORIDE, with a corresponding application number 211962.

Regulatory Information RX

With a dosage strength EQ 2GM BASE/400ML (EQ 5MG BASE/ML)

Dosage Form Route SOLUTION; INTRAVENOUS

Reference Listed Drug Yes

Approved since 2019-02-15

17

Xellia Pharmaceuticals ApS, based in Denmark, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is VANCOMYCIN HYDROCHLORIDE, with a corresponding application number 211962.

Regulatory Information RX

With a dosage strength EQ 1GM BASE/200ML (EQ 5MG BASE/ML)

Dosage Form Route SOLUTION; INTRAVENOUS

Reference Listed Drug Yes

Approved since 2019-02-15

16

Xellia Pharmaceuticals ApS, based in Denmark, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is VANCOMYCIN HYDROCHLORIDE, with a corresponding application number 211962.

Regulatory Information RX

With a dosage strength EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML)

Dosage Form Route SOLUTION; INTRAVENOUS

Reference Listed Drug Yes

Approved since 2020-05-13

15

Xellia Pharmaceuticals ApS, based in Denmark, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is VANCOMYCIN HYDROCHLORIDE, with a corresponding application number 211962.

Regulatory Information RX

With a dosage strength EQ 750MG BASE/150ML (EQ 5MG BASE/ML)

Dosage Form Route SOLUTION; INTRAVENOUS

Reference Listed Drug Yes

Approved since 2020-05-13

14

Xellia Pharmaceuticals ApS, based in Denmark, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is VANCOMYCIN HYDROCHLORIDE, with a corresponding application number 211962.

Regulatory Information RX

With a dosage strength EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)

Dosage Form Route SOLUTION; INTRAVENOUS

Reference Listed Drug Yes

Approved since 2019-02-15

13

Xellia Pharmaceuticals ApS, based in Denmark, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is VANCOMYCIN HYDROCHLORIDE, with a corresponding application number 211962.

Regulatory Information RX

With a dosage strength EQ 500MG BASE/100ML (EQ 5MG BASE/ML)

Dosage Form Route SOLUTION; INTRAVENOUS

Reference Listed Drug Yes

Approved since 2019-02-15

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