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Approved Drug Products of Exela Pharma Sciences, Llc. listed in the FDA Orange Book. Original Data : FDA Website

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01 2ACETYLCYSTEINE

02 2CAFFEINE CITRATE

03 1CUPRIC CHLORIDE

04 2CYSTEINE HYDROCHLORIDE

05 2DICLOFENAC SODIUM; MISOPROSTOL

06 2DILTIAZEM HYDROCHLORIDE

07 2EPHEDRINE SULFATE

08 1ERYTHROMYCIN LACTOBIONATE

09 2FENTANYL CITRATE

10 1GANCICLOVIR

11 4GLYCOPYRROLATE

12 1MAGNESIUM SULFATE

13 2MIDAZOLAM

14 3NEOSTIGMINE METHYLSULFATE

15 3PHENYLEPHRINE HYDROCHLORIDE

16 2POTASSIUM ACETATE

17 3SODIUM BICARBONATE

18 3SODIUM NITROPRUSSIDE

19 1TRANEXAMIC ACID

20 2VERAPAMIL HYDROCHLORIDE

21 1ZINC CHLORIDE

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01

Brand Name : ACETYLCYSTEINE

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Brand Name : ACETYLCYSTEINE

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Exela Pharma Sciences, LLC.

Dosage Form : INJECTABLE; INTRAVENOUS

Proprietary Name : ACETYLCYSTEINE

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

Approval Date : 2021-04-15

Application Number : 204797

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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02

Brand Name : ACETYLCYSTEINE

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Brand Name : ACETYLCYSTEINE

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Exela Pharma Sciences, LLC.

Dosage Form : SOLUTION; INHALATION, ORAL

Proprietary Name : ACETYLCYSTEINE

Dosage Strength : 20%

Approval Date : 2023-11-01

Application Number : 205643

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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03

Brand Name : CAFFEINE CITRATE

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Brand Name : CAFFEINE CITRATE

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Exela Pharma Sciences, LLC.

Dosage Form : SOLUTION; INTRAVENOUS

Proprietary Name : CAFFEINE CITRATE

Dosage Strength : EQ 30MG BASE/3ML (EQ 10M...

Approval Date : 2006-09-21

Application Number : 77233

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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04

Brand Name : CAFFEINE CITRATE

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Brand Name : CAFFEINE CITRATE

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Not Confirmed
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Exela Pharma Sciences, LLC.

Dosage Form : SOLUTION; ORAL

Proprietary Name : CAFFEINE CITRATE

Dosage Strength : EQ 30MG BASE/3ML (EQ 10M...

Approval Date : 2006-09-21

Application Number : 77304

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

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05

Brand Name : CUPRIC CHLORIDE

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Brand Name : CUPRIC CHLORIDE

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Exela Pharma Sciences, LLC.

Dosage Form : INJECTABLE; INJECTION

Proprietary Name : CUPRIC CHLORIDE

Dosage Strength : EQ 0.4MG COPPER/ML

Approval Date : 2022-10-31

Application Number : 212071

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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06

Brand Name : ELCYS

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Brand Name : ELCYS

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Exela Pharma Sciences, LLC.

Dosage Form : SOLUTION; INTRAVENOUS

Proprietary Name : ELCYS

Dosage Strength : 500MG/10ML (50MG/ML)

Approval Date : 2019-04-16

Application Number : 210660

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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07

Brand Name : ELCYS

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Brand Name : ELCYS

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Exela Pharma Sciences, LLC.

Dosage Form : SOLUTION; INTRAVENOUS

Proprietary Name : ELCYS

Dosage Strength : 2500MG/50ML (50MG/ML)

Approval Date : 2023-12-04

Application Number : 210660

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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08

Brand Name : DICLOFENAC SODIUM AN...

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Brand Name : DICLOFENAC SODIUM AN...

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Exela Pharma Sciences, LLC.

Dosage Form : TABLET, DELAYED RELEASE; ORAL

Proprietary Name : DICLOFENAC SODIUM AND MI...

Dosage Strength : 50MG;0.2MG

Approval Date : 2014-03-14

Application Number : 200540

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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09

Brand Name : DICLOFENAC SODIUM AN...

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Brand Name : DICLOFENAC SODIUM AN...

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Exela Pharma Sciences, LLC.

Dosage Form : TABLET, DELAYED RELEASE; ORAL

Proprietary Name : DICLOFENAC SODIUM AND MI...

Dosage Strength : 75MG;0.2MG

Approval Date : 2014-03-14

Application Number : 200540

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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10

Brand Name : DILTIAZEM HYDROCHLOR...

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Brand Name : DILTIAZEM HYDROCHLOR...

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Exela Pharma Sciences, LLC.

Dosage Form : SOLUTION; INTRAVENOUS

Proprietary Name : DILTIAZEM HYDROCHLORIDE ...

Dosage Strength : 125MG/125ML (1MG/ML) **F...

Approval Date : 2021-10-28

Application Number : 215252

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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