DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1Dr. Reddy's Laboratories
02 2American Regent
03 1Amneal Pharmaceuticals
04 1Apotex Inc
05 4Farbe Firma
06 1Fresenius Kabi USA
07 1GLAND PHARMA LIMITED
08 1Hanlim Pharmaceuticals Inc
09 3Hikma Pharmaceuticals
10 1Hospira, Inc.
11 1Igenius Life Sciences
12 2Lupin Ltd
13 1NORVIUM BIOSCIENCE
14 4Pfizer Inc
15 1SEARCHLIGHT PHARMA
16 1Sun Pharmaceutical Industries Limited
17 1Wockhardt
01 1CONCENTRATE FOR SOLUTION FOR INJECTION
02 1Concentrate for injection/infusion solution, solution
03 15INJECTABLE;INJECTION
04 1INJECTION
05 5Injection
06 1SOLUTION
07 2SOLUTION;INTRAVENOUS
08 1To concentrate the Injection/infusion fluid, resolution
01 9DISCN
02 1Generic
03 1Prescription
04 8RX
05 8Blank
01 1CELEBYX
02 2CEREBYX
03 14FOSPHENYTOIN SODIUM
04 3Pro-Epanutin
05 2SESQUIENT
06 5Blank
01 1Canada
02 5India
03 2Norway
04 1South Korea
05 1Sweden
06 17USA
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : DISCN
Registration Country : USA
Brand Name : FOSPHENYTOIN SODIUM
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 50MG PHENYTOIN NA/ML
Packaging :
Approval Date : 2007-08-06
Application Number : 76886
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : FOSPHENYTOIN SODIUM
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 50MG PHENYTOIN NA/ML
Packaging :
Approval Date : 2007-08-06
Application Number : 78277
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : FOSPHENYTOIN SODIUM
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 50MG PHENYTOIN NA/ML
Packaging :
Approval Date : 2010-05-13
Application Number : 90099
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : FOSPHENYTOIN SODIUM
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 50MG PHENYTOIN NA/ML
Packaging :
Approval Date : 2008-03-18
Application Number : 78476
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : FOSPHENYTOIN SODIUM
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 50MG PHENYTOIN NA/ML
Packaging :
Approval Date : 2007-08-06
Application Number : 78126
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 50MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 50MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 50MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 50MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info : RX
Registration Country : USA
Brand Name : FOSPHENYTOIN SODIUM
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 50MG PHENYTOIN NA/ML
Packaging :
Approval Date : 2007-08-06
Application Number : 78052
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : FOSPHENYTOIN SODIUM
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 50MG PHENYTOIN NA/ML
Packaging :
Approval Date : 2023-10-13
Application Number : 214926
Regulatory Info : RX
Registration Country : USA
Regulatory Info : Generic
Registration Country : South Korea
Brand Name : CELEBYX
Dosage Form : INJECTION
Dosage Strength : 75MG
Packaging : 2mL*10A, 10mL*5A
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Korea
Regulatory Info : RX
Registration Country : USA
Brand Name : FOSPHENYTOIN SODIUM
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 50MG PHENYTOIN NA/ML
Packaging :
Approval Date : 2007-08-06
Application Number : 77481
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : FOSPHENYTOIN SODIUM
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 50MG PHENYTOIN NA/ML
Packaging :
Approval Date : 2007-08-06
Application Number : 77989
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : FOSPHENYTOIN SODIUM
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 50MG PHENYTOIN NA/ML
Packaging :
Approval Date : 2009-12-02
Application Number : 78765
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : FOSPHENYTOIN SODIUM
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 50MG PHENYTOIN NA/ML
Packaging :
Approval Date : 2007-08-06
Application Number : 78158
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 75mg/2ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info : DISCN
Registration Country : USA
Brand Name : SESQUIENT
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : EQ 100MG PHENYTOIN NA/2ML (EQ 50MG PHENYTOIN NA/ML)
Packaging :
Approval Date : 2020-11-05
Application Number : 210864
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : SESQUIENT
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : EQ 500MG PHENYTOIN NA/10ML (EQ 50MG PHENYTOIN NA/ML)
Packaging :
Approval Date : 2020-11-05
Application Number : 210864
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : CEREBYX
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 50MG PHENYTOIN NA/ML
Packaging :
Approval Date : 1996-08-05
Application Number : 20450
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Sweden
Brand Name : Pro-Epanutin
Dosage Form : CONCENTRATE FOR SOLUTION FOR INJECTION
Dosage Strength : 75 MG / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Norway
Brand Name : Pro-Epanutin
Dosage Form : To concentrate the Injection/infusion fluid, resolution
Dosage Strength : 50 FNE mg/ml
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Pro-Epanutin
Dosage Form : Concentrate for injection/infusion solution, solution
Dosage Strength : 75 mg/ml
Packaging : Vials 10 10ml
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : CEREBYX
Dosage Form : SOLUTION
Dosage Strength : 75MG/ML
Packaging : 5X2ML/1X10ML
Approval Date :
Application Number : 2230988
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : RX
Registration Country : USA
Brand Name : FOSPHENYTOIN SODIUM
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 50MG PHENYTOIN NA/ML
Packaging :
Approval Date : 2008-03-18
Application Number : 78417
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : FOSPHENYTOIN SODIUM
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 50MG PHENYTOIN NA/ML
Packaging :
Approval Date : 2007-08-06
Application Number : 78137
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : FOSPHENYTOIN SODIUM
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 50MG PHENYTOIN NA/ML
Packaging :
Approval Date : 2010-06-08
Application Number : 78736
Regulatory Info : DISCN
Registration Country : USA
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