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Approved Drug Products containing 20287 listed in the FDA Orange Book. Original Data : FDA Website

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01 PFIZER (12)

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01 INJECTABLE;INJECTION (1)

02 INJECTABLE;SUBCUTANEOUS (11)

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01 DISCN (3)

02 RX (9)

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01 FRAGMIN (12)

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01 No (3)

02 Yes (9)

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INJECTABLE; SUBCUT...
2,500IU/0.2ML (12,...
1994-12-22
20287
FRAGMIN
RX
Yes
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INJECTABLE; INJECT...
7,500 IU/0.75ML
2002-04-04
20287
FRAGMIN
DISCN
No
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INJECTABLE; SUBCUT...
95,000IU/3.8ML (25...
2002-04-04
20287
FRAGMIN
RX
Yes
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INJECTABLE; SUBCUT...
10,000IU/ML (10,00...
1998-01-30
20287
FRAGMIN
RX
Yes
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INJECTABLE; SUBCUT...
10,000IU/0.4ML (25...
2007-05-01
20287
FRAGMIN
DISCN
No
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INJECTABLE; SUBCUT...
12,500IU/0.5ML (25...
2007-05-01
20287
FRAGMIN
RX
Yes
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INJECTABLE; SUBCUT...
95,000IU/9.5ML (10...
2002-04-04
20287
FRAGMIN
DISCN
No
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INJECTABLE; SUBCUT...
7,500IU/0.3ML (25,...
2002-04-04
20287
FRAGMIN
RX
Yes
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INJECTABLE; SUBCUT...
5,000IU/0.2ML (25,...
1996-03-18
20287
FRAGMIN
RX
Yes
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INJECTABLE; SUBCUT...
15,000IU/0.6ML (25...
2007-05-01
20287
FRAGMIN
RX
Yes
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Looking for FDA Orange Book APPLICATION 20287

Looking for FDA Orange Book APPLICATION 20287 10

19

Pfizer Inc, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is DALTEPARIN SODIUM, with a corresponding application number 20287.

Regulatory Information RX

With a dosage strength 2,500IU/0.2ML (12,500IU/ML)

Dosage Form Route INJECTABLE; SUBCUTANEOUS

Reference Listed Drug Yes

Approved since 1994-12-22

18

Pfizer Inc, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is DALTEPARIN SODIUM, with a corresponding application number 20287.

Regulatory Information DISCN

With a dosage strength 7,500 IU/0.75ML

Dosage Form Route INJECTABLE; INJECTION

Reference Listed Drug No

Approved since 2002-04-04

17

Pfizer Inc, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is DALTEPARIN SODIUM, with a corresponding application number 20287.

Regulatory Information RX

With a dosage strength 95,000IU/3.8ML (25,000IU/ML)

Dosage Form Route INJECTABLE; SUBCUTANEOUS

Reference Listed Drug Yes

Approved since 2002-04-04

16

Pfizer Inc, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is DALTEPARIN SODIUM, with a corresponding application number 20287.

Regulatory Information RX

With a dosage strength 10,000IU/ML (10,000IU/ML)

Dosage Form Route INJECTABLE; SUBCUTANEOUS

Reference Listed Drug Yes

Approved since 1998-01-30

15

Pfizer Inc, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is DALTEPARIN SODIUM, with a corresponding application number 20287.

Regulatory Information DISCN

With a dosage strength 10,000IU/0.4ML (25,000IU/ML)

Dosage Form Route INJECTABLE; SUBCUTANEOUS

Reference Listed Drug No

Approved since 2007-05-01

14

Pfizer Inc, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is DALTEPARIN SODIUM, with a corresponding application number 20287.

Regulatory Information RX

With a dosage strength 12,500IU/0.5ML (25,000IU/ML)

Dosage Form Route INJECTABLE; SUBCUTANEOUS

Reference Listed Drug Yes

Approved since 2007-05-01

13

Pfizer Inc, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is DALTEPARIN SODIUM, with a corresponding application number 20287.

Regulatory Information DISCN

With a dosage strength 95,000IU/9.5ML (10,000IU/ML)

Dosage Form Route INJECTABLE; SUBCUTANEOUS

Reference Listed Drug No

Approved since 2002-04-04

12

Pfizer Inc, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is DALTEPARIN SODIUM, with a corresponding application number 20287.

Regulatory Information RX

With a dosage strength 7,500IU/0.3ML (25,000IU/ML)

Dosage Form Route INJECTABLE; SUBCUTANEOUS

Reference Listed Drug Yes

Approved since 2002-04-04

11

Pfizer Inc, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is DALTEPARIN SODIUM, with a corresponding application number 20287.

Regulatory Information RX

With a dosage strength 5,000IU/0.2ML (25,000IU/ML)

Dosage Form Route INJECTABLE; SUBCUTANEOUS

Reference Listed Drug Yes

Approved since 1996-03-18

10

Pfizer Inc, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is DALTEPARIN SODIUM, with a corresponding application number 20287.

Regulatory Information RX

With a dosage strength 15,000IU/0.6ML (25,000IU/ML)

Dosage Form Route INJECTABLE; SUBCUTANEOUS

Reference Listed Drug Yes

Approved since 2007-05-01

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