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Approved Drug Products containing 20800 listed in the FDA Orange Book. Original Data : FDA Website

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01 IMPAX (4)

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01 INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS (4)

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01 DISCN (2)

02 RX (2)

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01 ADRENACLICK (2)

02 TWINJECT 0.15 (1)

03 TWINJECT 0.3 (1)

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01 No (2)

02 Yes (2)

URL Supplier Web Content
INJECTABLE; INTRAM...
EQ 0.3MG/DELIVERY
2003-05-30
20800
TWINJECT 0.3
DISCN
No
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INJECTABLE; INTRAM...
EQ 0.3MG/DELIVERY
2009-11-25
20800
ADRENACLICK
RX
Yes
BX
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INJECTABLE; INTRAM...
EQ 0.15MG/DELIVERY
2004-05-28
20800
TWINJECT 0.15
DISCN
No
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INJECTABLE; INTRAM...
EQ 0.15MG/DELIVERY
2009-11-25
20800
ADRENACLICK
RX
Yes
BX
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Looking for FDA Orange Book APPLICATION 20800

Looking for FDA Orange Book APPLICATION 20800 4

19

Impax Laboratories, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is EPINEPHRINE, with a corresponding application number 20800.

Regulatory Information DISCN

With a dosage strength EQ 0.3MG/DELIVERY

Dosage Form Route INJECTABLE; INTRAMUSCULAR, SUBCUTANEOUS

Reference Listed Drug No

Approved since 2003-05-30

18

Impax Laboratories, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is EPINEPHRINE, with a corresponding application number 20800.

Regulatory Information RX

With a dosage strength EQ 0.3MG/DELIVERY

Dosage Form Route INJECTABLE; INTRAMUSCULAR, SUBCUTANEOUS

Reference Listed Drug Yes

Approved since 2009-11-25

Therapeutic Equivalence (TE) Code BX

17

Impax Laboratories, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is EPINEPHRINE, with a corresponding application number 20800.

Regulatory Information DISCN

With a dosage strength EQ 0.15MG/DELIVERY

Dosage Form Route INJECTABLE; INTRAMUSCULAR, SUBCUTANEOUS

Reference Listed Drug No

Approved since 2004-05-28

16

Impax Laboratories, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is EPINEPHRINE, with a corresponding application number 20800.

Regulatory Information RX

With a dosage strength EQ 0.15MG/DELIVERY

Dosage Form Route INJECTABLE; INTRAMUSCULAR, SUBCUTANEOUS

Reference Listed Drug Yes

Approved since 2009-11-25

Therapeutic Equivalence (TE) Code BX

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