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Approved Drug Products containing 9218 listed in the FDA Orange Book. Original Data : FDA Website

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01 BRISTOL MYERS SQUIBB (12)

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01 INJECTABLE;INJECTION (3)

02 TABLET;ORAL (9)

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01 DISCN (12)

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01 COUMADIN (12)

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01 No (3)

02 Yes (9)

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TABLET; ORAL
2.5MG
1982-01-01
9218
COUMADIN
DISCN
Yes
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TABLET; ORAL
2MG
1982-01-01
9218
COUMADIN
DISCN
Yes
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TABLET; ORAL
5MG
1982-01-01
9218
COUMADIN
DISCN
Yes
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TABLET; ORAL
4MG
1993-08-24
9218
COUMADIN
DISCN
Yes
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INJECTABLE; INJECT...
50MG/VIAL
1982-01-01
9218
COUMADIN
DISCN
No
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TABLET; ORAL
7.5MG
1982-01-01
9218
COUMADIN
DISCN
Yes
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INJECTABLE; INJECT...
75MG/VIAL
1982-01-01
9218
COUMADIN
DISCN
No
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INJECTABLE; INJECT...
5MG/VIAL
1995-02-07
9218
COUMADIN
DISCN
No
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TABLET; ORAL
10MG
1982-01-01
9218
COUMADIN
DISCN
Yes
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TABLET; ORAL
1MG **Federal Regi...
1990-03-01
9218
COUMADIN
DISCN
Yes
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Looking for FDA Orange Book APPLICATION 9218

Looking for FDA Orange Book APPLICATION 9218 10

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 WARFARIN SODIUM, with a corresponding application number 9218.

Regulatory Information DISCN

With a dosage strength 2.5MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 1982-01-01

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 WARFARIN SODIUM, with a corresponding application number 9218.

Regulatory Information DISCN

With a dosage strength 2MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 1982-01-01

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 WARFARIN SODIUM, with a corresponding application number 9218.

Regulatory Information DISCN

With a dosage strength 5MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 1982-01-01

16

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 WARFARIN SODIUM, with a corresponding application number 9218.

Regulatory Information DISCN

With a dosage strength 4MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 1993-08-24

15

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 WARFARIN SODIUM, with a corresponding application number 9218.

Regulatory Information DISCN

With a dosage strength 50MG/VIAL

Dosage Form Route INJECTABLE; INJECTION

Reference Listed Drug No

Approved since 1982-01-01

14

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 WARFARIN SODIUM, with a corresponding application number 9218.

Regulatory Information DISCN

With a dosage strength 7.5MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 1982-01-01

13

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 WARFARIN SODIUM, with a corresponding application number 9218.

Regulatory Information DISCN

With a dosage strength 75MG/VIAL

Dosage Form Route INJECTABLE; INJECTION

Reference Listed Drug No

Approved since 1982-01-01

12

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 WARFARIN SODIUM, with a corresponding application number 9218.

Regulatory Information DISCN

With a dosage strength 5MG/VIAL

Dosage Form Route INJECTABLE; INJECTION

Reference Listed Drug No

Approved since 1995-02-07

11

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 WARFARIN SODIUM, with a corresponding application number 9218.

Regulatory Information DISCN

With a dosage strength 10MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 1982-01-01

10

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 WARFARIN SODIUM, with a corresponding application number 9218.

Regulatory Information DISCN

With a dosage strength 1MG **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 1990-03-01

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