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

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01 4ACTAVIS LABS FL INC

02 8ASCENT PHARMS INC

03 3AUROLIFE PHARMA LLC

04 1BARR

05 7FRESENIUS KABI USA

06 4GENUS

07 9HIKMA

08 1HOSPIRA

09 6HOSPIRA INC

10 2LANNETT

11 3NESHER PHARMS

12 1NOSTRUM LABS INC

13 4OSMOTICA PHARM US

14 4PADAGIS US

15 4PURDUE PHARMA LP

16 4RHODES PHARMS

17 2RISING PHARMA

18 7SPECGX LLC

19 1WATSON LABS

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01

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HYDROMORPHONE HYDROCHLORIDE

Brand Name : DILAUDID-HP

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 10MG/ML

Approval Date : 1984-01-11

Application Number : 19034

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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HYDROMORPHONE HYDROCHLORIDE

Brand Name : DILAUDID-HP

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 250MG/VIAL

Approval Date : 1994-08-04

Application Number : 19034

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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03

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HYDROMORPHONE HYDROCHLORIDE

Brand Name : DILAUDID

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 1MG/ML

Approval Date : 2009-04-30

Application Number : 19034

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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HYDROMORPHONE HYDROCHLORIDE

Brand Name : DILAUDID

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 2MG/ML

Approval Date : 2009-04-30

Application Number : 19034

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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HYDROMORPHONE HYDROCHLORIDE

Brand Name : DILAUDID

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 4MG/ML

Approval Date : 2009-04-30

Application Number : 19034

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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HYDROMORPHONE HYDROCHLORIDE

Brand Name : DILAUDID

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 0.2MG/ML

Approval Date : 2020-01-16

Application Number : 19034

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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HYDROMORPHONE HYDROCHLORIDE

Brand Name : DILAUDID

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 0.5MG/0.5ML

Approval Date : 2017-02-10

Application Number : 19034

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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HYDROMORPHONE HYDROCHLORIDE

Brand Name : DILAUDID

Dosage Form : SOLUTION;ORAL

Dosage Strength : 5MG/5ML

Approval Date : 1992-12-07

Application Number : 19891

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AA

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HYDROMORPHONE HYDROCHLORIDE

Brand Name : DILAUDID

Dosage Form : TABLET;ORAL

Dosage Strength : 8MG

Approval Date : 1992-12-07

Application Number : 19892

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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HYDROMORPHONE HYDROCHLORIDE

Brand Name : DILAUDID

Dosage Form : TABLET;ORAL

Dosage Strength : 4MG

Approval Date : 2007-11-09

Application Number : 19892

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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