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Approved Drug Products containing Azithromycin, unspecified form listed in the FDA Orange Book. Original Data : FDA Website

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01 1TARO

02 2ACI

03 3ALEMBIC

04 2AMNEAL

05 3APOTEX CORP

06 4AUROBINDO PHARMA LTD

07 1AUROBINDO PHARMA USA

08 3BIONPHARMA

09 5CHARTWELL RX

10 3CSPC OUYI

11 2EPIC PHARMA LLC

12 1EUGIA PHARMA

13 1EXTROVIS

14 1FRESENIUS KABI USA

15 1GLAND PHARMA LTD

16 2HAINAN POLY

17 1HIKMA

18 2HOSPIRA

19 3LUPIN LTD

20 2NORVIUM BIOSCIENCE

21 2NOVEL LABS INC

22 1PF PRISM CV

23 8PFIZER

24 5PLIVA

25 1RISING

26 5SANDOZ

27 1SANDOZ INC

28 1SLATE RUN PHARMA

29 1SUN PHARM INDS LTD

30 3SUNSHINE

31 3TEVA

32 2TEVA PARENTERAL

33 2TEVA PHARMS

34 1THEA PHARMA

35 3YUNG SHIN PHARM

36 2ZYDUS LIFESCIENCES

37 2ZYDUS PHARMS

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PharmaCompass

01

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Not Confirmed

AZITHROMYCIN

Brand Name : AZITHROMYCIN

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : EQ 200MG BASE/5ML

Approval Date : 2019-12-11

Application Number : 211521

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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02

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Not Confirmed
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Not Confirmed

AZITHROMYCIN

Brand Name : ZITHROMAX

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1991-11-01

Application Number : 50670

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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03

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Not Confirmed
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Not Confirmed

AZITHROMYCIN

Brand Name : ZITHROMAX

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : EQ 1GM BASE/PACKET

Approval Date : 1994-09-28

Application Number : 50693

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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04

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Not Confirmed
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Not Confirmed

AZITHROMYCIN

Brand Name : ZITHROMAX

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : EQ 100MG BASE/5ML

Approval Date : 1995-10-19

Application Number : 50710

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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05

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Not Confirmed
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Not Confirmed

AZITHROMYCIN

Brand Name : ZITHROMAX

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : EQ 200MG BASE/5ML

Approval Date : 1995-10-19

Application Number : 50710

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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06

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Not Confirmed
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Not Confirmed

AZITHROMYCIN

Brand Name : ZITHROMAX

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 250MG BASE

Approval Date : 1996-07-18

Application Number : 50711

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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07

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Not Confirmed
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Not Confirmed

AZITHROMYCIN

Brand Name : ZITHROMAX

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 600MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1996-06-12

Application Number : 50730

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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08

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Not Confirmed
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Not Confirmed

AZITHROMYCIN

Brand Name : ZITHROMAX

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 500MG BASE/VIAL

Approval Date : 1997-01-30

Application Number : 50733

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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09

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Not Confirmed
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Not Confirmed

AZITHROMYCIN

Brand Name : ZITHROMAX

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 500MG BASE

Approval Date : 2002-05-24

Application Number : 50784

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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10

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Not Confirmed
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Not Confirmed

AZITHROMYCIN

Brand Name : ZMAX

Dosage Form : FOR SUSPENSION, EXTENDED RELEASE;ORAL

Dosage Strength : EQ 2GM BASE/BOT

Approval Date : 2005-06-10

Application Number : 50797

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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