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Approved Drug Products containing 85031 listed in the FDA Orange Book. Original Data : FDA Website

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01 ANI PHARMS (4)

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01 TABLET;ORAL (4)

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01 DISCN (4)

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01 AMITRIPTYLINE HYDROCHLORIDE (4)

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01 No (4)

URL Supplier Web Content
TABLET; ORAL
10MG
1982-01-01
85031
AMITRIPTYLINE HYDR...
DISCN
No
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URL Supplier Web Content
TABLET; ORAL
50MG
1982-01-01
85031
AMITRIPTYLINE HYDR...
DISCN
No
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URL Supplier Web Content
TABLET; ORAL
25MG
1982-01-01
85031
AMITRIPTYLINE HYDR...
DISCN
No
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TABLET; ORAL
75MG
1982-01-01
85031
AMITRIPTYLINE HYDR...
DISCN
No
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Looking for FDA Orange Book APPLICATION 85031

Looking for FDA Orange Book APPLICATION 85031 4

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 AMITRIPTYLINE HYDROCHLORIDE, with a corresponding application number 85031.

Regulatory Information DISCN

With a dosage strength 10MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 1982-01-01

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 AMITRIPTYLINE HYDROCHLORIDE, with a corresponding application number 85031.

Regulatory Information DISCN

With a dosage strength 50MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 1982-01-01

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 AMITRIPTYLINE HYDROCHLORIDE, with a corresponding application number 85031.

Regulatory Information DISCN

With a dosage strength 25MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 1982-01-01

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 AMITRIPTYLINE HYDROCHLORIDE, with a corresponding application number 85031.

Regulatory Information DISCN

With a dosage strength 75MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 1982-01-01

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