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Approved Drug Products containing 21951 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 CAPSULE;ORAL (6)

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01 RX (6)

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01 ABSORICA (6)

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01 Yes (6)

URL Supplier Web Content
CAPSULE; ORAL
25MG
2014-08-15
21951
ABSORICA
RX
Yes
AB2
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CAPSULE; ORAL
30MG
2012-05-25
21951
ABSORICA
RX
Yes
AB2
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CAPSULE; ORAL
10MG
2012-05-25
21951
ABSORICA
RX
Yes
AB2
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CAPSULE; ORAL
35MG
2014-08-15
21951
ABSORICA
RX
Yes
AB2
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CAPSULE; ORAL
40MG
2012-05-25
21951
ABSORICA
RX
Yes
AB2
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CAPSULE; ORAL
20MG
2012-05-25
21951
ABSORICA
RX
Yes
AB2
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Looking for FDA Orange Book APPLICATION 21951

Looking for FDA Orange Book APPLICATION 21951 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 ISOTRETINOIN, with a corresponding application number 21951.

Regulatory Information RX

With a dosage strength 25MG

Dosage Form Route CAPSULE; ORAL

Reference Listed Drug Yes

Approved since 2014-08-15

Therapeutic Equivalence (TE) Code AB2

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 ISOTRETINOIN, with a corresponding application number 21951.

Regulatory Information RX

With a dosage strength 30MG

Dosage Form Route CAPSULE; ORAL

Reference Listed Drug Yes

Approved since 2012-05-25

Therapeutic Equivalence (TE) Code AB2

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 ISOTRETINOIN, with a corresponding application number 21951.

Regulatory Information RX

With a dosage strength 10MG

Dosage Form Route CAPSULE; ORAL

Reference Listed Drug Yes

Approved since 2012-05-25

Therapeutic Equivalence (TE) Code AB2

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 ISOTRETINOIN, with a corresponding application number 21951.

Regulatory Information RX

With a dosage strength 35MG

Dosage Form Route CAPSULE; ORAL

Reference Listed Drug Yes

Approved since 2014-08-15

Therapeutic Equivalence (TE) Code AB2

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 ISOTRETINOIN, with a corresponding application number 21951.

Regulatory Information RX

With a dosage strength 40MG

Dosage Form Route CAPSULE; ORAL

Reference Listed Drug Yes

Approved since 2012-05-25

Therapeutic Equivalence (TE) Code AB2

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 ISOTRETINOIN, with a corresponding application number 21951.

Regulatory Information RX

With a dosage strength 20MG

Dosage Form Route CAPSULE; ORAL

Reference Listed Drug Yes

Approved since 2012-05-25

Therapeutic Equivalence (TE) Code AB2

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