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Approved Drug Products containing Tox21_300307 listed in the FDA Orange Book. Original Data : FDA Website

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ABBVIE INC

ACTAVIS LABS UT INC

ALLERGAN SALES LLC

ALZA

AMNEAL PHARMS NY

BIONPHARMA INC

DR REDDYS

EUGIA PHARMA

FERRING

FRESENIUS KABI USA

HIKMA FARMACEUTICA

LILLY

LUITPOLD

SANDOZ INC

SOFGEN PHARMS

TEVA PHARMS

THERAPEUTICSMD INC

VIRTUS PHARMS

WATSON LABS INC

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CAPSULE; ORAL

CAPSULE;ORAL

GEL;VAGINAL

INJECTABLE;INJECTION

INSERT, EXTENDED RELEASE;INTRAUTERINE

INSERT;VAGINAL

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DISCN

RX

Blank

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BIJUVA

CRINONE

ENDOMETRIN

PROGESTASERT

PROGESTERONE

PROMETRIUM

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No

Yes

Blank

Request an Update of Your Company Information, Events & Sales Content

Dosage Form Route

CAPSULE; ORAL

Dosage Strength

100MG

Approval Date

Application Number

20843

Brand Name

PROMETRIUM

RX/OTC/DISCN

RLD

TE Code

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Dosage Form Route

CAPSULE; ORAL

Dosage Strength

300MG

Approval Date

Application Number

20843

Brand Name

PROMETRIUM

RX/OTC/DISCN

RLD

TE Code

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Dosage Form Route

CAPSULE; ORAL

Dosage Strength

200MG

Approval Date

Application Number

20843

Brand Name

PROMETRIUM

RX/OTC/DISCN

RLD

TE Code

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Dosage Form Route

GEL;VAGINAL

Dosage Strength

8%

Approval Date

Application Number

20756

Brand Name

CRINONE

RX/OTC/DISCN

RLD

TE Code

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Dosage Form Route

INJECTABLE;INJECTION

Dosage Strength

50MG/ML

Approval Date

1982-01-01

Application Number

17362

Brand Name

PROGESTERONE

RX/OTC/DISCN

RX

RLD

Yes

TE Code

AO

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Dosage Form Route

GEL;VAGINAL

Dosage Strength

8%

Approval Date

1997-07-31

Application Number

20701

Brand Name

CRINONE

RX/OTC/DISCN

RX

RLD

Yes

TE Code

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Dosage Form Route

GEL;VAGINAL

Dosage Strength

4%

Approval Date

1997-07-31

Application Number

20701

Brand Name

CRINONE

RX/OTC/DISCN

RX

RLD

Yes

TE Code

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Dosage Form Route

CAPSULE;ORAL

Dosage Strength

100MG

Approval Date

2017-09-07

Application Number

207724

Brand Name

PROGESTERONE

RX/OTC/DISCN

RX

RLD

No

TE Code

AB

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Dosage Form Route

CAPSULE;ORAL

Dosage Strength

200MG

Approval Date

2017-09-07

Application Number

207724

Brand Name

PROGESTERONE

RX/OTC/DISCN

RX

RLD

No

TE Code

AB

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Dosage Form Route

CAPSULE;ORAL

Dosage Strength

200MG

Approval Date

2013-08-16

Application Number

200900

Brand Name

PROGESTERONE

RX/OTC/DISCN

RX

RLD

No

TE Code

AB

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Dosage Form Route

CAPSULE;ORAL

Dosage Strength

100MG

Approval Date

2013-08-16

Application Number

200900

Brand Name

PROGESTERONE

RX/OTC/DISCN

RX

RLD

No

TE Code

AB

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Dosage Form Route

INJECTABLE;INJECTION

Dosage Strength

25MG/ML

Approval Date

1982-01-01

Application Number

9238

Brand Name

PROGESTERONE

RX/OTC/DISCN

DISCN

RLD

No

TE Code

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Dosage Form Route

INJECTABLE;INJECTION

Dosage Strength

50MG/ML

Approval Date

1982-01-01

Application Number

9238

Brand Name

PROGESTERONE

RX/OTC/DISCN

DISCN

RLD

No

TE Code

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Dosage Form Route

INSERT;VAGINAL

Dosage Strength

100MG

Approval Date

2007-06-21

Application Number

22057

Brand Name

ENDOMETRIN

RX/OTC/DISCN

RX

RLD

Yes

TE Code

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Dosage Form Route

INJECTABLE;INJECTION

Dosage Strength

50MG/ML

Approval Date

2001-04-25

Application Number

75906

Brand Name

PROGESTERONE

RX/OTC/DISCN

RX

RLD

No

TE Code

AO

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Dosage Form Route

INJECTABLE;INJECTION

Dosage Strength

50MG/ML

Approval Date

2010-10-28

Application Number

91033

Brand Name

PROGESTERONE

RX/OTC/DISCN

RX

RLD

No

TE Code

AO

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Dosage Form Route

INJECTABLE;INJECTION

Dosage Strength

50MG/ML

Approval Date

2009-06-22

Application Number

90845

Brand Name

PROGESTERONE

RX/OTC/DISCN

DISCN

RLD

No

TE Code

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Dosage Form Route

CAPSULE;ORAL

Dosage Strength

200MG

Approval Date

2017-10-20

Application Number

205229

Brand Name

PROGESTERONE

RX/OTC/DISCN

RX

RLD

No

TE Code

AB

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Dosage Form Route

CAPSULE;ORAL

Dosage Strength

100MG

Approval Date

2017-10-20

Application Number

205229

Brand Name

PROGESTERONE

RX/OTC/DISCN

RX

RLD

No

TE Code

AB

Request an Update of Your Company Information, Events & Sales Content

Dosage Form Route

CAPSULE;ORAL

Dosage Strength

200MG

Approval Date

2012-09-28

Application Number

200456

Brand Name

PROGESTERONE

RX/OTC/DISCN

RX

RLD

No

TE Code

AB

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Dosage Form Route

CAPSULE;ORAL

Dosage Strength

100MG

Approval Date

2012-09-28

Application Number

200456

Brand Name

PROGESTERONE

RX/OTC/DISCN

RX

RLD

No

TE Code

AB

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Dosage Form Route

CAPSULE;ORAL

Dosage Strength

200MG

Approval Date

2012-02-29

Application Number

202121

Brand Name

PROGESTERONE

RX/OTC/DISCN

DISCN

RLD

No

TE Code

Request an Update of Your Company Information, Events & Sales Content

Dosage Form Route

CAPSULE;ORAL

Dosage Strength

100MG

Approval Date

2012-02-29

Application Number

202121

Brand Name

PROGESTERONE

RX/OTC/DISCN

DISCN

RLD

No

TE Code

Request an Update of Your Company Information, Events & Sales Content

Dosage Form Route

CAPSULE;ORAL

Dosage Strength

200MG

Approval Date

1999-10-15

Application Number

19781

Brand Name

PROMETRIUM

RX/OTC/DISCN

RX

RLD

Yes

TE Code

AB

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Dosage Form Route

CAPSULE;ORAL

Dosage Strength

100MG

Approval Date

1998-05-14

Application Number

19781

Brand Name

PROMETRIUM

RX/OTC/DISCN

RX

RLD

Yes

TE Code

AB

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Dosage Form Route

CAPSULE;ORAL

Dosage Strength

300MG

Approval Date

1999-10-15

Application Number

19781

Brand Name

PROMETRIUM

RX/OTC/DISCN

DISCN

RLD

No

TE Code

DR REDDYS

Request an Update of Your Company Information, Events & Sales Content

Dosage Form Route

CAPSULE;ORAL

Dosage Strength

100MG

Approval Date

2017-02-28

Application Number

208801

Brand Name

PROGESTERONE

RX/OTC/DISCN

RX

RLD

No

TE Code

AB

THERAPEUTICSMD INC

Request an Update of Your Company Information, Events & Sales Content

Dosage Form Route

CAPSULE;ORAL

Dosage Strength

1MG;100MG

Approval Date

2018-10-28

Application Number

210132

Brand Name

BIJUVA

RX/OTC/DISCN

RX

RLD

Yes

TE Code

EUGIA PHARMA

Request an Update of Your Company Information, Events & Sales Content

Dosage Form Route

CAPSULE;ORAL

Dosage Strength

100MG

Approval Date

2018-10-26

Application Number

211285

Brand Name

PROGESTERONE

RX/OTC/DISCN

RX

RLD

No

TE Code

AB

ALZA

Request an Update of Your Company Information, Events & Sales Content

Dosage Form Route

INSERT, EXTENDED RELEASE;INTRAUTERINE

Dosage Strength

38MG

Approval Date

1982-01-01

Application Number

17553

Brand Name

PROGESTASERT

RX/OTC/DISCN

DISCN

RLD

No

TE Code

DR REDDYS

Request an Update of Your Company Information, Events & Sales Content

Dosage Form Route

CAPSULE;ORAL

Dosage Strength

200MG

Approval Date

2017-02-28

Application Number

208801

Brand Name

PROGESTERONE

RX/OTC/DISCN

RX

RLD

No

TE Code

AB

EUGIA PHARMA

Request an Update of Your Company Information, Events & Sales Content

Dosage Form Route

INJECTABLE;INJECTION

Dosage Strength

50MG/ML

Approval Date

2018-12-06

Application Number

210965

Brand Name

PROGESTERONE

RX/OTC/DISCN

RX

RLD

No

TE Code

AO

EUGIA PHARMA

Request an Update of Your Company Information, Events & Sales Content

Dosage Form Route

CAPSULE;ORAL

Dosage Strength

200MG

Approval Date

2018-10-26

Application Number

211285

Brand Name

PROGESTERONE

RX/OTC/DISCN

RX

RLD

No

TE Code

AB

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