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Approved Drug Products containing (1-34)-Human parathormone listed in the FDA Orange Book. Original Data : FDA Website

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01 1ALMAJECT

02 1ALVOGEN

03 1APOTEX

04 2LILLY

05 1TEVA PHARMS USA

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PharmaCompass

01

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

TERIPARATIDE

Brand Name : TERIPARATIDE

Dosage Form : SOLUTION;SUBCUTANEOUS

Dosage Strength : 0.6MG/2.4ML (0.25MG/ML)

Approval Date : 2024-06-04

Application Number : 218771

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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02

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

TERIPARATIDE

Brand Name : BONSITY

Dosage Form : SOLUTION;SUBCUTANEOUS

Dosage Strength : 0.62MG/2.48ML (0.25MG/ML)

Approval Date : 2019-10-04

Application Number : 211939

RX/OTC/DISCN : RX

RLD : No

TE Code :

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03

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

TERIPARATIDE

Brand Name : TERIPARATIDE

Dosage Form : SOLUTION;SUBCUTANEOUS

Dosage Strength : 0.6MG/2.4ML (0.25MG/ML)

Approval Date : 2023-11-16

Application Number : 211097

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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04

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

TERIPARATIDE

Brand Name : FORTEO

Dosage Form : SOLUTION;SUBCUTANEOUS

Dosage Strength : 0.75MG/3ML (0.25MG/ML)

Approval Date : 2002-11-26

Application Number : 21318

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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05

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

TERIPARATIDE

Brand Name : FORTEO

Dosage Form : SOLUTION;SUBCUTANEOUS

Dosage Strength : 0.6MG/2.4ML (0.25MG/ML)

Approval Date : 2008-06-25

Application Number : 21318

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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06

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

TERIPARATIDE

Brand Name : TERIPARATIDE

Dosage Form : SOLUTION;SUBCUTANEOUS

Dosage Strength : 0.6MG/2.4ML (0.25MG/ML)

Approval Date : 2023-11-16

Application Number : 208569

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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