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Approved Drug Products containing 50580 listed in the FDA Orange Book. Original Data : FDA Website

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01 BRISTOL MYERS SQUIBB (3)

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01 INJECTABLE;INJECTION (3)

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01 DISCN (1)

02 RX (2)

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01 AZACTAM (3)

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01 No (1)

02 Yes (2)

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INJECTABLE; INJECT...
500MG/VIAL **Feder...
1986-12-31
50580
AZACTAM
DISCN
No
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INJECTABLE; INJECT...
1GM/VIAL
1986-12-31
50580
AZACTAM
RX
Yes
AP
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INJECTABLE; INJECT...
2GM/VIAL
1986-12-31
50580
AZACTAM
RX
Yes
AP
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Looking for FDA Orange Book APPLICATION 50580

Looking for FDA Orange Book APPLICATION 50580 3

19

Bristol Myers Squibb, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is AZTREONAM, with a corresponding application number 50580.

Regulatory Information DISCN

With a dosage strength 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route INJECTABLE; INJECTION

Reference Listed Drug No

Approved since 1986-12-31

18

Bristol Myers Squibb, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is AZTREONAM, with a corresponding application number 50580.

Regulatory Information RX

With a dosage strength 1GM/VIAL

Dosage Form Route INJECTABLE; INJECTION

Reference Listed Drug Yes

Approved since 1986-12-31

Therapeutic Equivalence (TE) Code AP

17

Bristol Myers Squibb, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is AZTREONAM, with a corresponding application number 50580.

Regulatory Information RX

With a dosage strength 2GM/VIAL

Dosage Form Route INJECTABLE; INJECTION

Reference Listed Drug Yes

Approved since 1986-12-31

Therapeutic Equivalence (TE) Code AP

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