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01 4ACTAVIS LABS FL INC

02 8ASCENT PHARMS INC

03 3AUROLIFE PHARMA LLC

04 1BARR

05 4CHARTWELL

06 7FRESENIUS KABI USA

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

18 7SPECGX LLC

19 1WATSON LABS

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PharmaCompass

01

euroPLX 86 Munich
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euroPLX 86 Munich
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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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02

euroPLX 86 Munich
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euroPLX 86 Munich
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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

euroPLX 86 Munich
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euroPLX 86 Munich
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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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04

euroPLX 86 Munich
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euroPLX 86 Munich
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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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05

euroPLX 86 Munich
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euroPLX 86 Munich
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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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06

euroPLX 86 Munich
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euroPLX 86 Munich
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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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07

euroPLX 86 Munich
Not Confirmed
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euroPLX 86 Munich
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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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08

euroPLX 86 Munich
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euroPLX 86 Munich
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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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09

euroPLX 86 Munich
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euroPLX 86 Munich
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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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10

euroPLX 86 Munich
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euroPLX 86 Munich
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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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