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Approved Drug Products containing 5010 listed in the FDA Orange Book. Original Data : FDA Website

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01 VALIDUS PHARMS (7)

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01 INJECTABLE;INJECTION (4)

02 SYRUP;ORAL (1)

03 TABLET;ORAL (2)

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01 DISCN (7)

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01 DEMEROL (7)

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01 No (5)

02 Yes (2)

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INJECTABLE; INJECT...
75MG/ML
1982-01-01
5010
DEMEROL
DISCN
No
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SYRUP; ORAL
50MG/5ML **Federal...
1982-01-01
5010
DEMEROL
DISCN
No
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INJECTABLE; INJECT...
100MG/ML
1982-01-01
5010
DEMEROL
DISCN
No
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TABLET; ORAL
50MG **Federal Reg...
1982-01-01
5010
DEMEROL
DISCN
Yes
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INJECTABLE; INJECT...
25MG/ML
1982-01-01
5010
DEMEROL
DISCN
No
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TABLET; ORAL
100MG
1982-01-01
5010
DEMEROL
DISCN
Yes
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INJECTABLE; INJECT...
50MG/ML
1982-01-01
5010
DEMEROL
DISCN
No
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Looking for FDA Orange Book APPLICATION 5010

Looking for FDA Orange Book APPLICATION 5010 7

19

VALIDUS PHARMS, based in U.S.A, is a pharmaceutical company.

One of their notable products is MEPERIDINE HYDROCHLORIDE, with a corresponding application number 5010.

Regulatory Information DISCN

With a dosage strength 75MG/ML

Dosage Form Route INJECTABLE; INJECTION

Reference Listed Drug No

Approved since 1982-01-01

18

VALIDUS PHARMS, based in U.S.A, is a pharmaceutical company.

One of their notable products is MEPERIDINE HYDROCHLORIDE, with a corresponding application number 5010.

Regulatory Information DISCN

With a dosage strength 50MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route SYRUP; ORAL

Reference Listed Drug No

Approved since 1982-01-01

17

VALIDUS PHARMS, based in U.S.A, is a pharmaceutical company.

One of their notable products is MEPERIDINE HYDROCHLORIDE, with a corresponding application number 5010.

Regulatory Information DISCN

With a dosage strength 100MG/ML

Dosage Form Route INJECTABLE; INJECTION

Reference Listed Drug No

Approved since 1982-01-01

16

VALIDUS PHARMS, based in U.S.A, is a pharmaceutical company.

One of their notable products is MEPERIDINE HYDROCHLORIDE, with a corresponding application number 5010.

Regulatory Information DISCN

With a dosage strength 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 1982-01-01

15

VALIDUS PHARMS, based in U.S.A, is a pharmaceutical company.

One of their notable products is MEPERIDINE HYDROCHLORIDE, with a corresponding application number 5010.

Regulatory Information DISCN

With a dosage strength 25MG/ML

Dosage Form Route INJECTABLE; INJECTION

Reference Listed Drug No

Approved since 1982-01-01

14

VALIDUS PHARMS, based in U.S.A, is a pharmaceutical company.

One of their notable products is MEPERIDINE HYDROCHLORIDE, with a corresponding application number 5010.

Regulatory Information DISCN

With a dosage strength 100MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 1982-01-01

13

VALIDUS PHARMS, based in U.S.A, is a pharmaceutical company.

One of their notable products is MEPERIDINE HYDROCHLORIDE, with a corresponding application number 5010.

Regulatory Information DISCN

With a dosage strength 50MG/ML

Dosage Form Route INJECTABLE; INJECTION

Reference Listed Drug No

Approved since 1982-01-01

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