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Approved Drug Products containing 11522 listed in the FDA Orange Book. Original Data : FDA Website

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01 TEVA WOMENS (7)

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01 TABLET;ORAL (7)

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01 DISCN (7)

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01 ADDERALL 10 (1)

02 ADDERALL 12.5 (1)

03 ADDERALL 15 (1)

04 ADDERALL 20 (1)

05 ADDERALL 30 (1)

06 ADDERALL 5 (1)

07 ADDERALL 7.5 (1)

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01 Yes (7)

URL Supplier Web Content
TABLET; ORAL
3.125MG;3.125MG;3....
2000-08-31
11522
ADDERALL 12.5
DISCN
Yes
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TABLET; ORAL
7.5MG;7.5MG;7.5MG;...
1997-05-12
11522
ADDERALL 30
DISCN
Yes
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TABLET; ORAL
5MG;5MG;5MG;5MG **...
1996-02-13
11522
ADDERALL 20
DISCN
Yes
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TABLET; ORAL
3.75MG;3.75MG;3.75...
2000-08-31
11522
ADDERALL 15
DISCN
Yes
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TABLET; ORAL
1.875MG;1.875MG;1....
2000-08-31
11522
ADDERALL 7.5
DISCN
Yes
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TABLET; ORAL
1.25MG;1.25MG;1.25...
1997-05-12
11522
ADDERALL 5
DISCN
Yes
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TABLET; ORAL
2.5MG;2.5MG;2.5MG;...
1996-02-13
11522
ADDERALL 10
DISCN
Yes
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Looking for FDA Orange Book APPLICATION 11522

Looking for FDA Orange Book APPLICATION 11522 7

19

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

One of their notable products is AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE, with a corresponding application number 11522.

Regulatory Information DISCN

With a dosage strength 3.125MG;3.125MG;3.125MG;3.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 2000-08-31

18

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

One of their notable products is AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE, with a corresponding application number 11522.

Regulatory Information DISCN

With a dosage strength 7.5MG;7.5MG;7.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 1997-05-12

17

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

One of their notable products is AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE, with a corresponding application number 11522.

Regulatory Information DISCN

With a dosage strength 5MG;5MG;5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 1996-02-13

16

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

One of their notable products is AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE, with a corresponding application number 11522.

Regulatory Information DISCN

With a dosage strength 3.75MG;3.75MG;3.75MG;3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 2000-08-31

15

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

One of their notable products is AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE, with a corresponding application number 11522.

Regulatory Information DISCN

With a dosage strength 1.875MG;1.875MG;1.875MG;1.875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 2000-08-31

14

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

One of their notable products is AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE, with a corresponding application number 11522.

Regulatory Information DISCN

With a dosage strength 1.25MG;1.25MG;1.25MG;1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 1997-05-12

13

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

One of their notable products is AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE, with a corresponding application number 11522.

Regulatory Information DISCN

With a dosage strength 2.5MG;2.5MG;2.5MG;2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 1996-02-13

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