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Approved Drug Products containing 50558 listed in the FDA Orange Book. Original Data : FDA Website

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01 PAI HOLDINGS PHARM (3)

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01 INJECTABLE;INJECTION (2)

02 INJECTABLE;INTRAMUSCULAR, INTRAVENOUS (1)

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01 DISCN (3)

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01 ZINACEF (3)

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01 Yes (3)

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INJECTABLE; INJECT...
EQ 1.5GM BASE/VIAL
1983-10-19
50558
ZINACEF
DISCN
Yes
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INJECTABLE; INJECT...
EQ 7.5GM BASE/VIAL
1986-10-23
50558
ZINACEF
DISCN
Yes
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INJECTABLE; INTRAM...
EQ 750MG BASE/VIAL
1983-10-19
50558
ZINACEF
DISCN
Yes
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Looking for FDA Orange Book APPLICATION 50558

Looking for FDA Orange Book APPLICATION 50558 3

19

PAI Pharmaceutical Associates, based in U.S.A, is a pharmaceutical company that stands out with its certifications from WHO-GMP.

One of their notable products is CEFUROXIME SODIUM, with a corresponding application number 50558.

Regulatory Information DISCN

With a dosage strength EQ 1.5GM BASE/VIAL

Dosage Form Route INJECTABLE; INJECTION

Reference Listed Drug Yes

Approved since 1983-10-19

18

PAI Pharmaceutical Associates, based in U.S.A, is a pharmaceutical company that stands out with its certifications from WHO-GMP.

One of their notable products is CEFUROXIME SODIUM, with a corresponding application number 50558.

Regulatory Information DISCN

With a dosage strength EQ 7.5GM BASE/VIAL

Dosage Form Route INJECTABLE; INJECTION

Reference Listed Drug Yes

Approved since 1986-10-23

17

PAI Pharmaceutical Associates, based in U.S.A, is a pharmaceutical company that stands out with its certifications from WHO-GMP.

One of their notable products is CEFUROXIME SODIUM, with a corresponding application number 50558.

Regulatory Information DISCN

With a dosage strength EQ 750MG BASE/VIAL

Dosage Form Route INJECTABLE; INTRAMUSCULAR, INTRAVENOUS

Reference Listed Drug Yes

Approved since 1983-10-19

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