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

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MEDROXYPROGESTERONE ACETATE

Brand Name : PROVERA

Dosage Form : TABLET;ORAL

Dosage Strength : 2.5MG

Approval Date : 1982-01-01

Application Number : 11839

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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02

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MEDROXYPROGESTERONE ACETATE

Brand Name : PROVERA

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Approval Date : 1982-01-01

Application Number : 11839

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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03

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MEDROXYPROGESTERONE ACETATE

Brand Name : PROVERA

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 1982-01-01

Application Number : 11839

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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04

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MEDROXYPROGESTERONE ACETATE

Brand Name : DEPO-PROVERA

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 12541

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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05

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MEDROXYPROGESTERONE ACETATE

Brand Name : DEPO-PROVERA

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 400MG/ML

Approval Date : 1982-01-01

Application Number : 12541

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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06

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MEDROXYPROGESTERONE ACETATE

Brand Name : DEPO-PROVERA

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 150MG/ML

Approval Date : 1992-10-29

Application Number : 20246

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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07

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ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE

Brand Name : PREMPRO (PREMARIN;CYCRIN)

Dosage Form : TABLET;ORAL-28

Dosage Strength : 0.625MG,0.625MG;2.5MG,2.5MG

Approval Date : 1994-12-30

Application Number : 20303

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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08

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ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE

Brand Name : PREMPHASE (PREMARIN;CYCRIN 14/14)

Dosage Form : TABLET;ORAL-28

Dosage Strength : 0.625MG,0.625MG;N/A,5MG

Approval Date : 1994-12-30

Application Number : 20303

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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09

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ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE

Brand Name : PREMPRO

Dosage Form : TABLET;ORAL-28

Dosage Strength : 0.625MG;2.5MG

Approval Date : 1995-11-17

Application Number : 20527

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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10

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ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE

Brand Name : PREMPHASE 14/14

Dosage Form : TABLET;ORAL-28

Dosage Strength : 0.625MG,0.625MG;N/A,5MG

Approval Date : 1995-11-17

Application Number : 20527

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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