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Approved Drug Products containing 21038 listed in the FDA Orange Book. Original Data : FDA Website

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01 HOSPIRA (5)

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01 INJECTABLE;INJECTION (5)

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01 RX (5)

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01 PRECEDEX (5)

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01 Yes (5)

URL Supplier Web Content
INJECTABLE; INJECT...
EQ 200MCG BASE/50M...
2013-03-13
21038
PRECEDEX
RX
Yes
AP
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INJECTABLE; INJECT...
EQ 1MG BASE/250ML ...
2020-01-31
21038
PRECEDEX
RX
Yes
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INJECTABLE; INJECT...
EQ 400MCG BASE/100...
2013-03-13
21038
PRECEDEX
RX
Yes
AP
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INJECTABLE; INJECT...
EQ 200MCG BASE/2ML...
1999-12-17
21038
PRECEDEX
RX
Yes
AP
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INJECTABLE; INJECT...
EQ 80MCG BASE/20ML...
2014-11-14
21038
PRECEDEX
RX
Yes
AP
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Looking for FDA Orange Book APPLICATION 21038

Looking for FDA Orange Book APPLICATION 21038 5

19

Hospira, 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 DEXMEDETOMIDINE HYDROCHLORIDE, with a corresponding application number 21038.

Regulatory Information RX

With a dosage strength EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)

Dosage Form Route INJECTABLE; INJECTION

Reference Listed Drug Yes

Approved since 2013-03-13

Therapeutic Equivalence (TE) Code AP

18

Hospira, 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 DEXMEDETOMIDINE HYDROCHLORIDE, with a corresponding application number 21038.

Regulatory Information RX

With a dosage strength EQ 1MG BASE/250ML (EQ 4MCG BASE/ML)

Dosage Form Route INJECTABLE; INJECTION

Reference Listed Drug Yes

Approved since 2020-01-31

17

Hospira, 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 DEXMEDETOMIDINE HYDROCHLORIDE, with a corresponding application number 21038.

Regulatory Information RX

With a dosage strength EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)

Dosage Form Route INJECTABLE; INJECTION

Reference Listed Drug Yes

Approved since 2013-03-13

Therapeutic Equivalence (TE) Code AP

16

Hospira, 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 DEXMEDETOMIDINE HYDROCHLORIDE, with a corresponding application number 21038.

Regulatory Information RX

With a dosage strength EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)

Dosage Form Route INJECTABLE; INJECTION

Reference Listed Drug Yes

Approved since 1999-12-17

Therapeutic Equivalence (TE) Code AP

15

Hospira, 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 DEXMEDETOMIDINE HYDROCHLORIDE, with a corresponding application number 21038.

Regulatory Information RX

With a dosage strength EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)

Dosage Form Route INJECTABLE; INJECTION

Reference Listed Drug Yes

Approved since 2014-11-14

Therapeutic Equivalence (TE) Code AP

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