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Athena Athena

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Approved Drug Products containing 207533 listed in the FDA Orange Book. Original Data : FDA Website

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01 ALKERMES INC (4)

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01 SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR (4)

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01 RX (4)

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01 ARISTADA (4)

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01 Yes (4)

URL Supplier Web Content
SUSPENSION, EXTEND...
882MG/3.2ML (275.6...
2015-10-05
207533
ARISTADA
RX
Yes
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SUSPENSION, EXTEND...
441MG/1.6ML (275.6...
2015-10-05
207533
ARISTADA
RX
Yes
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SUSPENSION, EXTEND...
1064MG/3.9ML (272....
2017-06-05
207533
ARISTADA
RX
Yes
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SUSPENSION, EXTEND...
662MG/2.4ML (275.8...
2015-10-05
207533
ARISTADA
RX
Yes
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Looking for FDA Orange Book APPLICATION 207533

Looking for FDA Orange Book APPLICATION 207533 4

19

Alkermes Plc, based in Ireland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is ARIPIPRAZOLE LAUROXIL, with a corresponding application number 207533.

Regulatory Information RX

With a dosage strength 882MG/3.2ML (275.63MG/ML)

Dosage Form Route SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR

Reference Listed Drug Yes

Approved since 2015-10-05

18

Alkermes Plc, based in Ireland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is ARIPIPRAZOLE LAUROXIL, with a corresponding application number 207533.

Regulatory Information RX

With a dosage strength 441MG/1.6ML (275.63MG/ML)

Dosage Form Route SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR

Reference Listed Drug Yes

Approved since 2015-10-05

17

Alkermes Plc, based in Ireland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is ARIPIPRAZOLE LAUROXIL, with a corresponding application number 207533.

Regulatory Information RX

With a dosage strength 1064MG/3.9ML (272.82MG/ML)

Dosage Form Route SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR

Reference Listed Drug Yes

Approved since 2017-06-05

16

Alkermes Plc, based in Ireland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is ARIPIPRAZOLE LAUROXIL, with a corresponding application number 207533.

Regulatory Information RX

With a dosage strength 662MG/2.4ML (275.83MG/ML)

Dosage Form Route SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR

Reference Listed Drug Yes

Approved since 2015-10-05

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