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Approved Drug Products containing 205401 listed in the FDA Orange Book. Original Data : FDA Website

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01 ANI PHARMS (6)

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01 CAPSULE, EXTENDED RELEASE;ORAL (6)

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01 RX (6)

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01 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (6)

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01 No (6)

URL Supplier Web Content
CAPSULE, EXTENDED ...
1.25MG;1.25MG;1.25...
2019-01-22
205401
DEXTROAMP SACCHARA...
RX
No
AB1
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CAPSULE, EXTENDED ...
7.5MG;7.5MG;7.5MG;...
2019-01-22
205401
DEXTROAMP SACCHARA...
RX
No
AB1
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CAPSULE, EXTENDED ...
5MG;5MG;5MG;5MG
2019-01-22
205401
DEXTROAMP SACCHARA...
RX
No
AB1
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CAPSULE, EXTENDED ...
2.5MG;2.5MG;2.5MG;...
2019-01-22
205401
DEXTROAMP SACCHARA...
RX
No
AB1
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URL Supplier Web Content
CAPSULE, EXTENDED ...
6.25MG;6.25MG;6.25...
2019-01-22
205401
DEXTROAMP SACCHARA...
RX
No
AB1
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CAPSULE, EXTENDED ...
3.75MG;3.75MG;3.75...
2019-01-22
205401
DEXTROAMP SACCHARA...
RX
No
AB1
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Looking for FDA Orange Book APPLICATION 205401

Looking for FDA Orange Book APPLICATION 205401 6

19

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

One of their notable products is AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE, with a corresponding application number 205401.

Regulatory Information RX

With a dosage strength 1.25MG;1.25MG;1.25MG;1.25MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug No

Approved since 2019-01-22

Therapeutic Equivalence (TE) Code AB1

18

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

One of their notable products is AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE, with a corresponding application number 205401.

Regulatory Information RX

With a dosage strength 7.5MG;7.5MG;7.5MG;7.5MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug No

Approved since 2019-01-22

Therapeutic Equivalence (TE) Code AB1

17

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

One of their notable products is AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE, with a corresponding application number 205401.

Regulatory Information RX

With a dosage strength 5MG;5MG;5MG;5MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug No

Approved since 2019-01-22

Therapeutic Equivalence (TE) Code AB1

16

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

One of their notable products is AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE, with a corresponding application number 205401.

Regulatory Information RX

With a dosage strength 2.5MG;2.5MG;2.5MG;2.5MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug No

Approved since 2019-01-22

Therapeutic Equivalence (TE) Code AB1

15

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

One of their notable products is AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE, with a corresponding application number 205401.

Regulatory Information RX

With a dosage strength 6.25MG;6.25MG;6.25MG;6.25MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug No

Approved since 2019-01-22

Therapeutic Equivalence (TE) Code AB1

14

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

One of their notable products is AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE, with a corresponding application number 205401.

Regulatory Information RX

With a dosage strength 3.75MG;3.75MG;3.75MG;3.75MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug No

Approved since 2019-01-22

Therapeutic Equivalence (TE) Code AB1

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