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01 3Actavis Inc

02 12Apotex Inc

03 3Aurobindo Pharma Limited

04 4Barr Laboratories

05 1Effik Italia

06 2Exeltis

07 9Glenmark Pharmaceuticals

08 2Janssen-Cilag

09 8Johnson & Johnson Innovative Medicine

10 2Lupin Ltd

11 2McNeil Consumer Health

12 1Medicem

13 5NAARI PTE

14 1NeoFarma Pharmaceuticals Limited

15 3Novast Laboratories

16 2PH HEALTH

17 1Pfizer Inc

18 1Teva Pharmaceutical Industries

19 1Viatris

20 5Xiromed

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PharmaCompass

01

BOS Manchester
Not Confirmed
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BOS Manchester
Not Confirmed

ETHINYL ESTRADIOL; NORGESTIMATE

Brand Name : NORGESTIMATE AND ETHINYL ESTRADIOL

Dosage Form : TABLET;ORAL-28

Dosage Strength : 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG

Packaging :

Approval Date : 2006-08-17

Application Number : 76626

Regulatory Info : DISCN

Registration Country : USA

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02

BOS Manchester
Not Confirmed
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BOS Manchester
Not Confirmed

ETHINYL ESTRADIOL; NORGESTIMATE

Brand Name : NORGESTIMATE AND ETHINYL ESTRADIOL

Dosage Form : TABLET;ORAL-28

Dosage Strength : 0.035MG;0.25MG

Packaging :

Approval Date : 2006-08-17

Application Number : 76627

Regulatory Info : DISCN

Registration Country : USA

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03

BOS Manchester
Not Confirmed
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BOS Manchester
Not Confirmed

ETHINYL ESTRADIOL; NORGESTIMATE

Brand Name : NORGESTIMATE AND ETHINYL ESTRADIOL

Dosage Form : TABLET;ORAL-28

Dosage Strength : 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG

Packaging :

Approval Date : 2011-03-09

Application Number : 90479

Regulatory Info : DISCN

Registration Country : USA

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04

BOS Manchester
Not Confirmed
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BOS Manchester
Not Confirmed

ETHINYL ESTRADIOL; NORGESTIMATE

Brand Name : SPRINTEC

Dosage Form : TABLET;ORAL-28

Dosage Strength : 0.035MG;0.25MG

Packaging :

Approval Date : 2002-09-25

Application Number : 75804

Regulatory Info : RX

Registration Country : USA

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05

BOS Manchester
Not Confirmed
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BOS Manchester
Not Confirmed

ETHINYL ESTRADIOL; NORGESTIMATE

Brand Name : TRI-SPRINTEC

Dosage Form : TABLET;ORAL-28

Dosage Strength : 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG

Packaging :

Approval Date : 2003-12-29

Application Number : 75808

Regulatory Info : RX

Registration Country : USA

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06

BOS Manchester
Not Confirmed
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BOS Manchester
Not Confirmed

ETHINYL ESTRADIOL; NORGESTIMATE

Brand Name : TRI LO SPRINTEC

Dosage Form : TABLET;ORAL-28

Dosage Strength : 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG

Packaging :

Approval Date : 2009-06-29

Application Number : 76784

Regulatory Info : RX

Registration Country : USA

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07

BOS Manchester
Not Confirmed
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BOS Manchester
Not Confirmed

ESTRADIOL; NORGESTIMATE

Brand Name : ESTRADIOL AND NORGESTIMATE

Dosage Form : TABLET;ORAL

Dosage Strength : 1MG,1MG;N/A,0.09MG

Packaging :

Approval Date : 2005-04-29

Application Number : 76812

Regulatory Info : DISCN

Registration Country : USA

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08

BOS Manchester
Not Confirmed
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BOS Manchester
Not Confirmed

ETHINYL ESTRADIOL; NORGESTIMATE

Brand Name : ORTHO CYCLEN-21

Dosage Form : TABLET;ORAL-21

Dosage Strength : 0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1989-12-29

Application Number : 19653

Regulatory Info : DISCN

Registration Country : USA

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09

BOS Manchester
Not Confirmed
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BOS Manchester
Not Confirmed

ETHINYL ESTRADIOL; NORGESTIMATE

Brand Name : ORTHO CYCLEN-28

Dosage Form : TABLET;ORAL-28

Dosage Strength : 0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1989-12-29

Application Number : 19653

Regulatory Info : DISCN

Registration Country : USA

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10

BOS Manchester
Not Confirmed
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BOS Manchester
Not Confirmed

ETHINYL ESTRADIOL; NORGESTIMATE

Brand Name : ORTHO TRI-CYCLEN

Dosage Form : TABLET;ORAL-28

Dosage Strength : 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1992-07-03

Application Number : 19697

Regulatory Info : DISCN

Registration Country : USA

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11

BOS Manchester
Not Confirmed
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BOS Manchester
Not Confirmed

ETHINYL ESTRADIOL; NORGESTIMATE

Brand Name : ORTHO TRI-CYCLEN

Dosage Form : TABLET;ORAL-21

Dosage Strength : 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1992-07-03

Application Number : 19697

Regulatory Info : DISCN

Registration Country : USA

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12

BOS Manchester
Not Confirmed
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BOS Manchester
Not Confirmed

ETHINYL ESTRADIOL; NORGESTIMATE

Brand Name : ORTHO TRI-CYCLEN LO

Dosage Form : TABLET;ORAL-28

Dosage Strength : 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 2002-08-22

Application Number : 21241

Regulatory Info : DISCN

Registration Country : USA

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13

BOS Manchester
Not Confirmed
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BOS Manchester
Not Confirmed

ETHINYL ESTRADIOL; NORGESTIMATE

Brand Name : ORTHO TRI-CYCLEN 21

Dosage Form : TABLET; ORAL-21

Dosage Strength : 0.035MG,0.035MG,0.035MG; 0.18MG,0.215MG,0.25MG

Packaging :

Approval Date :

Application Number : 21690

Regulatory Info :

Registration Country : USA

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14

BOS Manchester
Not Confirmed
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BOS Manchester
Not Confirmed

ETHINYL ESTRADIOL; NORGESTIMATE

Brand Name : ORTHO TRI-CYCLEN 28

Dosage Form : TABLET; ORAL-28

Dosage Strength : 0.035MG,0.035MG,0.035MG; 0.18MG,0.215MG,0.25MG

Packaging :

Approval Date :

Application Number : 21690

Regulatory Info :

Registration Country : USA

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15

BOS Manchester
Not Confirmed
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BOS Manchester
Not Confirmed

ETHINYL ESTRADIOL; NORGESTIMATE

Brand Name : MONO-LINYAH

Dosage Form : TABLET;ORAL-28

Dosage Strength : 0.035MG;0.25MG

Packaging :

Approval Date : 2012-05-23

Application Number : 90523

Regulatory Info : RX

Registration Country : USA

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16

BOS Manchester
Not Confirmed
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BOS Manchester
Not Confirmed

ETHINYL ESTRADIOL; NORGESTIMATE

Brand Name : TRI-LINYAH

Dosage Form : TABLET;ORAL-28

Dosage Strength : 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG

Packaging :

Approval Date : 2012-05-30

Application Number : 90524

Regulatory Info : RX

Registration Country : USA

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17

BOS Manchester
Not Confirmed
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BOS Manchester
Not Confirmed

ETHINYL ESTRADIOL; NORGESTIMATE

Brand Name : TRI-LO-LINYAH

Dosage Form : TABLET;ORAL-28

Dosage Strength : 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG

Packaging :

Approval Date : 2022-09-02

Application Number : 90541

Regulatory Info : RX

Registration Country : USA

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18

BOS Manchester
Not Confirmed
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BOS Manchester
Not Confirmed

ESTRADIOL; NORGESTIMATE

Brand Name : PREFEST

Dosage Form : TABLET;ORAL

Dosage Strength : 1MG,1MG;N/A,0.09MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1999-10-22

Application Number : 21040

Regulatory Info : DISCN

Registration Country : USA

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19

PH HEALTH

Country
BOS Manchester
Not Confirmed
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PH HEALTH

Country
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BOS Manchester
Not Confirmed

ETHINYL ESTRADIOL; NORGESTIMATE

Brand Name : PREVIFEM

Dosage Form : TABLET;ORAL-28

Dosage Strength : 0.035MG;0.25MG

Packaging :

Approval Date : 2004-01-09

Application Number : 76334

Regulatory Info : RX

Registration Country : USA

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20

PH HEALTH

Country
BOS Manchester
Not Confirmed
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PH HEALTH

Country
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BOS Manchester
Not Confirmed

ETHINYL ESTRADIOL; NORGESTIMATE

Brand Name : TRI-PREVIFEM

Dosage Form : TABLET;ORAL-28

Dosage Strength : 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG

Packaging :

Approval Date : 2004-03-26

Application Number : 76335

Regulatory Info : DISCN

Registration Country : USA

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