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Approved Drug Products containing 214134 listed in the FDA Orange Book. Original Data : FDA Website

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01 SUN PHARM INDS INC (6)

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01 TABLET, CHEWABLE;ORAL (6)

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01 RX (6)

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01 LISDEXAMFETAMINE DIMESYLATE (6)

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01 No (6)

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TABLET, CHEWABLE; ...
50MG
2023-08-25
214134
LISDEXAMFETAMINE D...
RX
No
AB
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TABLET, CHEWABLE; ...
30MG
2023-08-25
214134
LISDEXAMFETAMINE D...
RX
No
AB
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TABLET, CHEWABLE; ...
10MG
2023-08-25
214134
LISDEXAMFETAMINE D...
RX
No
AB
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TABLET, CHEWABLE; ...
60MG
2023-08-25
214134
LISDEXAMFETAMINE D...
RX
No
AB
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TABLET, CHEWABLE; ...
40MG
2023-08-25
214134
LISDEXAMFETAMINE D...
RX
No
AB
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TABLET, CHEWABLE; ...
20MG
2023-08-25
214134
LISDEXAMFETAMINE D...
RX
No
AB
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Looking for FDA Orange Book APPLICATION 214134

Looking for FDA Orange Book APPLICATION 214134 6

19

Sun Pharmaceutical Industries Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is LISDEXAMFETAMINE DIMESYLATE, with a corresponding application number 214134.

Regulatory Information RX

With a dosage strength 50MG

Dosage Form Route TABLET, CHEWABLE; ORAL

Reference Listed Drug No

Approved since 2023-08-25

Therapeutic Equivalence (TE) Code AB

18

Sun Pharmaceutical Industries Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is LISDEXAMFETAMINE DIMESYLATE, with a corresponding application number 214134.

Regulatory Information RX

With a dosage strength 30MG

Dosage Form Route TABLET, CHEWABLE; ORAL

Reference Listed Drug No

Approved since 2023-08-25

Therapeutic Equivalence (TE) Code AB

17

Sun Pharmaceutical Industries Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is LISDEXAMFETAMINE DIMESYLATE, with a corresponding application number 214134.

Regulatory Information RX

With a dosage strength 10MG

Dosage Form Route TABLET, CHEWABLE; ORAL

Reference Listed Drug No

Approved since 2023-08-25

Therapeutic Equivalence (TE) Code AB

16

Sun Pharmaceutical Industries Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is LISDEXAMFETAMINE DIMESYLATE, with a corresponding application number 214134.

Regulatory Information RX

With a dosage strength 60MG

Dosage Form Route TABLET, CHEWABLE; ORAL

Reference Listed Drug No

Approved since 2023-08-25

Therapeutic Equivalence (TE) Code AB

15

Sun Pharmaceutical Industries Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is LISDEXAMFETAMINE DIMESYLATE, with a corresponding application number 214134.

Regulatory Information RX

With a dosage strength 40MG

Dosage Form Route TABLET, CHEWABLE; ORAL

Reference Listed Drug No

Approved since 2023-08-25

Therapeutic Equivalence (TE) Code AB

14

Sun Pharmaceutical Industries Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is LISDEXAMFETAMINE DIMESYLATE, with a corresponding application number 214134.

Regulatory Information RX

With a dosage strength 20MG

Dosage Form Route TABLET, CHEWABLE; ORAL

Reference Listed Drug No

Approved since 2023-08-25

Therapeutic Equivalence (TE) Code AB

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