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Approved Drug Products containing 21964 listed in the FDA Orange Book. Original Data : FDA Website

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01 SALIX PHARMS (3)

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01 SOLUTION;SUBCUTANEOUS (3)

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01 RX (3)

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01 RELISTOR (3)

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01 Yes (3)

URL Supplier Web Content
SOLUTION; SUBCUTAN...
8MG/0.4ML (8MG/0.4...
2010-09-27
21964
RELISTOR
RX
Yes
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URL Supplier Web Content
SOLUTION; SUBCUTAN...
12MG/0.6ML (12MG/0...
2010-09-27
21964
RELISTOR
RX
Yes
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SOLUTION; SUBCUTAN...
12MG/0.6ML (12MG/0...
2008-04-24
21964
RELISTOR
RX
Yes
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Looking for FDA Orange Book APPLICATION 21964

Looking for FDA Orange Book APPLICATION 21964 3

19

Salix Pharmaceuticals, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is METHYLNALTREXONE BROMIDE, with a corresponding application number 21964.

Regulatory Information RX

With a dosage strength 8MG/0.4ML (8MG/0.4ML)

Dosage Form Route SOLUTION; SUBCUTANEOUS

Reference Listed Drug Yes

Approved since 2010-09-27

18

Salix Pharmaceuticals, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is METHYLNALTREXONE BROMIDE, with a corresponding application number 21964.

Regulatory Information RX

With a dosage strength 12MG/0.6ML (12MG/0.6ML)

Dosage Form Route SOLUTION; SUBCUTANEOUS

Reference Listed Drug Yes

Approved since 2010-09-27

17

Salix Pharmaceuticals, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is METHYLNALTREXONE BROMIDE, with a corresponding application number 21964.

Regulatory Information RX

With a dosage strength 12MG/0.6ML (12MG/0.6ML)

Dosage Form Route SOLUTION; SUBCUTANEOUS

Reference Listed Drug Yes

Approved since 2008-04-24

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