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

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01 1ASPEN

02 2ALVOGEN

03 2AM REGENT

04 2APOTHECON

05 2ARBOR PHARMS LLC

06 1CUMBERLAND PHARMS

07 2DEY

08 1EUGIA PHARMA

09 2EXELA PHARMA

10 1FRESENIUS KABI USA

11 2GALEPHAR

12 4HOSPIRA

13 1INDOCO

14 1MEAD JOHNSON

15 2QUAD PHARMS

16 1RISING

17 1RISING PHARMA

18 4ROXANE

19 1SAGENT PHARMS INC

20 1SOMERSET THERAPS LLC

21 1STERISCIENCE SPECLTS

22 1ZYDUS PHARMS

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PharmaCompass

01

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AAPS 2024
Not Confirmed

ACETYLCYSTEINE

Brand Name : ACETYLCYSTEINE

Dosage Form : INJECTABLE;INTRAVENOUS

Dosage Strength : 6GM/30ML (200MG/ML)

Approval Date : 2022-02-03

Application Number : 213693

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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02

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

ACETYLCYSTEINE

Brand Name : MUCOMYST

Dosage Form : SOLUTION;INHALATION, ORAL

Dosage Strength : 20% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 13601

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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03

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

ACETYLCYSTEINE

Brand Name : MUCOMYST

Dosage Form : SOLUTION;INHALATION, ORAL

Dosage Strength : 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 13601

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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04

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

ACETYLCYSTEINE

Brand Name : ACETADOTE

Dosage Form : INJECTABLE;INTRAVENOUS

Dosage Strength : 6GM/30ML (200MG/ML)

Approval Date : 2004-01-23

Application Number : 21539

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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05

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

ACETYLCYSTEINE

Brand Name : MUCOSIL-10

Dosage Form : SOLUTION;INHALATION, ORAL

Dosage Strength : 10%

Approval Date : 1986-10-14

Application Number : 70575

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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06

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

ACETYLCYSTEINE

Brand Name : MUCOSIL-20

Dosage Form : SOLUTION;INHALATION, ORAL

Dosage Strength : 20%

Approval Date : 1986-10-14

Application Number : 70576

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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07

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

ACETYLCYSTEINE

Brand Name : ACETYLCYSTEINE

Dosage Form : SOLUTION;INHALATION, ORAL

Dosage Strength : 10%

Approval Date : 1989-05-01

Application Number : 71364

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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08

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

ACETYLCYSTEINE

Brand Name : ACETYLCYSTEINE

Dosage Form : SOLUTION;INHALATION, ORAL

Dosage Strength : 20%

Approval Date : 1989-05-01

Application Number : 71365

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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09

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

ACETYLCYSTEINE; ISOPROTERENOL HYDROCHLORIDE

Brand Name : MUCOMYST W/ ISOPROTERENOL

Dosage Form : SOLUTION;INHALATION

Dosage Strength : 10%;0.05%

Approval Date : 1982-01-01

Application Number : 17366

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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10

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

ACETYLCYSTEINE

Brand Name : ACETYLCYSTEINE

Dosage Form : Solution; Inhalation, Oral

Dosage Strength : 10%

Approval Date :

Application Number : 71740

RX/OTC/DISCN :

RLD :

TE Code :

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