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Approved Drug Products containing 77183 listed in the FDA Orange Book. Original Data : FDA Website

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01 DR REDDYS LABS INC (4)

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01 CAPSULE;ORAL (4)

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01 RX (4)

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01 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (4)

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01 No (4)

URL Supplier Web Content
CAPSULE; ORAL
EQ 5MG BASE;10MG
2010-04-15
77183
AMLODIPINE BESYLAT...
RX
No
AB
URL Supplier Web Content
CAPSULE; ORAL
EQ 5MG BASE;20MG
2010-04-15
77183
AMLODIPINE BESYLAT...
RX
No
AB
URL Supplier Web Content
CAPSULE; ORAL
EQ 2.5MG BASE;10MG
2010-04-15
77183
AMLODIPINE BESYLAT...
RX
No
AB
URL Supplier Web Content
CAPSULE; ORAL
EQ 10MG BASE;20MG
2010-04-15
77183
AMLODIPINE BESYLAT...
RX
No
AB

Looking for FDA Orange Book APPLICATION 77183

Looking for FDA Orange Book APPLICATION 77183 4

19

Dr. Reddy\'s Laboratories, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

One of their notable products is AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE, with a corresponding application number 77183.

Regulatory Information RX

With a dosage strength EQ 5MG BASE;10MG

Dosage Form Route CAPSULE; ORAL

Reference Listed Drug No

Approved since 2010-04-15

Therapeutic Equivalence (TE) Code AB

18

Dr. Reddy\'s Laboratories, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

One of their notable products is AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE, with a corresponding application number 77183.

Regulatory Information RX

With a dosage strength EQ 5MG BASE;20MG

Dosage Form Route CAPSULE; ORAL

Reference Listed Drug No

Approved since 2010-04-15

Therapeutic Equivalence (TE) Code AB

17

Dr. Reddy\'s Laboratories, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

One of their notable products is AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE, with a corresponding application number 77183.

Regulatory Information RX

With a dosage strength EQ 2.5MG BASE;10MG

Dosage Form Route CAPSULE; ORAL

Reference Listed Drug No

Approved since 2010-04-15

Therapeutic Equivalence (TE) Code AB

16

Dr. Reddy\'s Laboratories, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

One of their notable products is AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE, with a corresponding application number 77183.

Regulatory Information RX

With a dosage strength EQ 10MG BASE;20MG

Dosage Form Route CAPSULE; ORAL

Reference Listed Drug No

Approved since 2010-04-15

Therapeutic Equivalence (TE) Code AB

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