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Approved Drug Products containing AGN-PC-0JKHFR listed in the FDA Orange Book. Original Data : FDA Website

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01 1TARO

02 1STRIDES PHARMA

03 1ALKEM LABS LTD

04 2AMNEAL

05 1ANNORA PHARMA

06 4B BRAUN MEDICAL INC

07 2BAXTER HLTHCARE

08 4BAXTER HLTHCARE CORP

09 1BIONPHARMA

10 3BRAINTREE LABS

11 1EXELA PHARMA

12 17FRESENIUS KABI USA

13 1GATOR PHARMS

14 2GLAND PHARMA LTD

15 9HOSPIRA

16 6HQ SPCLT PHARMA

17 1LANNETT CO INC

18 1LUKARE MEDICAL LLC

19 3MILLA PHARMS

20 3MYLAN LABS LTD

21 1NOVEL LABS INC

22 1PADDOCK LLC

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

RLD : No

TE Code : AA

MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE

Brand Name : SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE

Dosage Form : SOLUTION;ORAL

Dosage Strength : 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT

Approval Date : 2023-11-22

Application Number : 215469

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

Strides Pharma Science

02

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ASC 2024
Not Confirmed

MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE

Brand Name : SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE

Dosage Form : SOLUTION;ORAL

Dosage Strength : 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT

Approval Date : 2024-03-19

Application Number : 206431

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

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03

ASC 2024
Not Confirmed
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ASC 2024
Not Confirmed

MAGNESIUM SULFATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM PHOSPHATE

Brand Name : TIS-U-SOL IN PLASTIC CONTAINER

Dosage Form : SOLUTION;IRRIGATION

Dosage Strength : 20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100ML

Approval Date : 1982-01-01

Application Number : 18336

RX/OTC/DISCN : RX

RLD : No

TE Code : AT

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04

ASC 2024
Not Confirmed
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ASC 2024
Not Confirmed

MAGNESIUM SULFATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM PHOSPHATE

Brand Name : TIS-U-SOL

Dosage Form : SOLUTION;IRRIGATION

Dosage Strength : 20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100ML

Approval Date : 1982-02-19

Application Number : 18508

RX/OTC/DISCN : RX

RLD : No

TE Code : AT

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05

ASC 2024
Not Confirmed
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ASC 2024
Not Confirmed

MAGNESIUM SULFATE

Brand Name : MAGNESIUM SULFATE

Dosage Form : SOLUTION;INTRAMUSCULAR, INTRAVENOUS

Dosage Strength : 5GM/10ML (500MG/ML)

Approval Date : 1986-09-08

Application Number : 19316

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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06

ASC 2024
Not Confirmed
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ASC 2024
Not Confirmed

MAGNESIUM SULFATE

Brand Name : MAGNESIUM SULFATE

Dosage Form : SOLUTION;INTRAMUSCULAR, INTRAVENOUS

Dosage Strength : 1GM/2ML (500MG/ML)

Approval Date : 1986-09-08

Application Number : 19316

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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07

ASC 2024
Not Confirmed
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ASC 2024
Not Confirmed

MAGNESIUM SULFATE

Brand Name : MAGNESIUM SULFATE

Dosage Form : SOLUTION;INTRAMUSCULAR, INTRAVENOUS

Dosage Strength : 10GM/20ML (500MG/ML)

Approval Date : 2016-01-29

Application Number : 19316

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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08

ASC 2024
Not Confirmed
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ASC 2024
Not Confirmed

MAGNESIUM SULFATE

Brand Name : MAGNESIUM SULFATE

Dosage Form : SOLUTION;INTRAMUSCULAR, INTRAVENOUS

Dosage Strength : 25GM/50ML (500MG/ML)

Approval Date : 2016-01-29

Application Number : 19316

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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09

ASC 2024
Not Confirmed
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ASC 2024
Not Confirmed

MAGNESIUM SULFATE

Brand Name : MAGNESIUM SULFATE IN PLASTIC CONTAINER

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 4GM/100ML (40MG/ML)

Approval Date : 1994-06-24

Application Number : 20309

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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10

ASC 2024
Not Confirmed
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ASC 2024
Not Confirmed

MAGNESIUM SULFATE

Brand Name : MAGNESIUM SULFATE IN PLASTIC CONTAINER

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 4GM/50ML (80MG/ML)

Approval Date : 1994-06-24

Application Number : 20309

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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