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Approved Drug Products containing 20837 listed in the FDA Orange Book. Original Data : FDA Website

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01 HIKMA (4)

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01 SOLUTION;INHALATION (4)

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01 RX (4)

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01 XOPENEX (4)

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01 Yes (4)

URL Supplier Web Content
SOLUTION; INHALATI...
EQ 0.0103% BASE
2002-01-30
20837
XOPENEX
RX
Yes
AN
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SOLUTION; INHALATI...
EQ 0.021% BASE
1999-03-25
20837
XOPENEX
RX
Yes
AN
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URL Supplier Web Content
SOLUTION; INHALATI...
EQ 0.25% BASE
2003-07-18
20837
XOPENEX
RX
Yes
AN
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URL Supplier Web Content
SOLUTION; INHALATI...
EQ 0.042% BASE
1999-03-25
20837
XOPENEX
RX
Yes
AN
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Looking for FDA Orange Book APPLICATION 20837

Looking for FDA Orange Book APPLICATION 20837 4

19

Hikma Pharmaceuticals, based in United Kingdom, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is LEVALBUTEROL HYDROCHLORIDE, with a corresponding application number 20837.

Regulatory Information RX

With a dosage strength EQ 0.0103% BASE

Dosage Form Route SOLUTION; INHALATION

Reference Listed Drug Yes

Approved since 2002-01-30

Therapeutic Equivalence (TE) Code AN

18

Hikma Pharmaceuticals, based in United Kingdom, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is LEVALBUTEROL HYDROCHLORIDE, with a corresponding application number 20837.

Regulatory Information RX

With a dosage strength EQ 0.021% BASE

Dosage Form Route SOLUTION; INHALATION

Reference Listed Drug Yes

Approved since 1999-03-25

Therapeutic Equivalence (TE) Code AN

17

Hikma Pharmaceuticals, based in United Kingdom, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is LEVALBUTEROL HYDROCHLORIDE, with a corresponding application number 20837.

Regulatory Information RX

With a dosage strength EQ 0.25% BASE

Dosage Form Route SOLUTION; INHALATION

Reference Listed Drug Yes

Approved since 2003-07-18

Therapeutic Equivalence (TE) Code AN

16

Hikma Pharmaceuticals, based in United Kingdom, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is LEVALBUTEROL HYDROCHLORIDE, with a corresponding application number 20837.

Regulatory Information RX

With a dosage strength EQ 0.042% BASE

Dosage Form Route SOLUTION; INHALATION

Reference Listed Drug Yes

Approved since 1999-03-25

Therapeutic Equivalence (TE) Code AN

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