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Approved Drug Products containing 77328 listed in the FDA Orange Book. Original Data : FDA Website

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01 DR REDDYS LABS LTD (5)

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01 TABLET, ORALLY DISINTEGRATING;ORAL (5)

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01 RX (5)

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01 RISPERIDONE (5)

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01 No (5)

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TABLET, ORALLY DIS...
3MG
2009-11-30
77328
RISPERIDONE
RX
No
AB
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TABLET, ORALLY DIS...
1MG
2009-10-05
77328
RISPERIDONE
RX
No
AB
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TABLET, ORALLY DIS...
4MG
2009-11-30
77328
RISPERIDONE
RX
No
AB
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TABLET, ORALLY DIS...
2MG
2009-02-24
77328
RISPERIDONE
RX
No
AB
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TABLET, ORALLY DIS...
0.5MG
2009-02-24
77328
RISPERIDONE
RX
No
AB
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Looking for FDA Orange Book APPLICATION 77328

Looking for FDA Orange Book APPLICATION 77328 5

19

XYZ Pharma, based in Gabon, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is RISPERIDONE, with a corresponding application number 77328.

Regulatory Information RX

With a dosage strength 3MG

Dosage Form Route TABLET, ORALLY DISINTEGRATING; ORAL

Reference Listed Drug No

Approved since 2009-11-30

Therapeutic Equivalence (TE) Code AB

18

XYZ Pharma, based in Gabon, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is RISPERIDONE, with a corresponding application number 77328.

Regulatory Information RX

With a dosage strength 1MG

Dosage Form Route TABLET, ORALLY DISINTEGRATING; ORAL

Reference Listed Drug No

Approved since 2009-10-05

Therapeutic Equivalence (TE) Code AB

17

XYZ Pharma, based in Gabon, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is RISPERIDONE, with a corresponding application number 77328.

Regulatory Information RX

With a dosage strength 4MG

Dosage Form Route TABLET, ORALLY DISINTEGRATING; ORAL

Reference Listed Drug No

Approved since 2009-11-30

Therapeutic Equivalence (TE) Code AB

16

XYZ Pharma, based in Gabon, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is RISPERIDONE, with a corresponding application number 77328.

Regulatory Information RX

With a dosage strength 2MG

Dosage Form Route TABLET, ORALLY DISINTEGRATING; ORAL

Reference Listed Drug No

Approved since 2009-02-24

Therapeutic Equivalence (TE) Code AB

15

XYZ Pharma, based in Gabon, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is RISPERIDONE, with a corresponding application number 77328.

Regulatory Information RX

With a dosage strength 0.5MG

Dosage Form Route TABLET, ORALLY DISINTEGRATING; ORAL

Reference Listed Drug No

Approved since 2009-02-24

Therapeutic Equivalence (TE) Code AB

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