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Approved Drug Products containing 91022 listed in the FDA Orange Book. Original Data : FDA Website

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01 SANDOZ (6)

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01 CAPSULE, EXTENDED RELEASE;ORAL (6)

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01 RX (6)

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01 DILTIAZEM HYDROCHLORIDE (6)

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01 No (6)

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CAPSULE, EXTENDED ...
420MG
2012-09-28
91022
DILTIAZEM HYDROCHL...
RX
No
AB4
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CAPSULE, EXTENDED ...
300MG
2012-09-28
91022
DILTIAZEM HYDROCHL...
RX
No
AB4
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CAPSULE, EXTENDED ...
180MG
2012-09-28
91022
DILTIAZEM HYDROCHL...
RX
No
AB4
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CAPSULE, EXTENDED ...
360MG
2012-09-28
91022
DILTIAZEM HYDROCHL...
RX
No
AB4
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CAPSULE, EXTENDED ...
240MG
2012-09-28
91022
DILTIAZEM HYDROCHL...
RX
No
AB4
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CAPSULE, EXTENDED ...
120MG
2012-09-28
91022
DILTIAZEM HYDROCHL...
RX
No
AB4
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Looking for FDA Orange Book APPLICATION 91022

Looking for FDA Orange Book APPLICATION 91022 6

19

Sandoz B2B, based in Switzerland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for A global leader in antibiotics.

One of their notable products is DILTIAZEM HYDROCHLORIDE, with a corresponding application number 91022.

Regulatory Information RX

With a dosage strength 420MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug No

Approved since 2012-09-28

Therapeutic Equivalence (TE) Code AB4

18

Sandoz B2B, based in Switzerland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for A global leader in antibiotics.

One of their notable products is DILTIAZEM HYDROCHLORIDE, with a corresponding application number 91022.

Regulatory Information RX

With a dosage strength 300MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug No

Approved since 2012-09-28

Therapeutic Equivalence (TE) Code AB4

17

Sandoz B2B, based in Switzerland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for A global leader in antibiotics.

One of their notable products is DILTIAZEM HYDROCHLORIDE, with a corresponding application number 91022.

Regulatory Information RX

With a dosage strength 180MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug No

Approved since 2012-09-28

Therapeutic Equivalence (TE) Code AB4

16

Sandoz B2B, based in Switzerland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for A global leader in antibiotics.

One of their notable products is DILTIAZEM HYDROCHLORIDE, with a corresponding application number 91022.

Regulatory Information RX

With a dosage strength 360MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug No

Approved since 2012-09-28

Therapeutic Equivalence (TE) Code AB4

15

Sandoz B2B, based in Switzerland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for A global leader in antibiotics.

One of their notable products is DILTIAZEM HYDROCHLORIDE, with a corresponding application number 91022.

Regulatory Information RX

With a dosage strength 240MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug No

Approved since 2012-09-28

Therapeutic Equivalence (TE) Code AB4

14

Sandoz B2B, based in Switzerland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for A global leader in antibiotics.

One of their notable products is DILTIAZEM HYDROCHLORIDE, with a corresponding application number 91022.

Regulatory Information RX

With a dosage strength 120MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug No

Approved since 2012-09-28

Therapeutic Equivalence (TE) Code AB4

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