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About the Company : At GSK we have a challenging mission: to improve the quality of human life by enabling people to do more, feel better, live longer. Find out how this shapes everything we do, including our R&D, ...
Regulatory Info : Originator
Registration Country : South Africa
Dosage Form : INJ
Brand Name : Fluarix Tetra
Dosage Strength : 15ug
Packaging : 0.5X1ug
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
A/michigan/45/2015 (h1n1) Pdm09
Dosage Form : INJ
Brand Name : Fluarix Tetra
Dosage Strength : 15ug
Packaging : 0.5X1ug
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info :
Registration Country : Switzerland
Dosage Form : Drinking Solution
Brand Name : Ziagen
Dosage Strength : 20mg/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Dosage Form : Tabl
Brand Name : Ziagen
Dosage Strength : 300mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info : Originator
Registration Country : South Africa
Dosage Form : TAB
Brand Name : Trizivar
Dosage Strength : 300mg
Packaging : 60X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Dosage Form : TAB
Brand Name : Kivexa
Dosage Strength : 600mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Dosage Form : TAB
Brand Name : Trelavue
Dosage Strength : 600mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Dosage Form : TAB
Brand Name : Ziagen Tablets
Dosage Strength : 300mg
Packaging : 60X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Dosage Form : SYR
Brand Name : Ziagen Oral Solution
Dosage Strength : 20mg/ml
Packaging : 240X1mg/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info :
Registration Country : Italy
Dosage Form : Abacavir 20Mg/Ml 240Ml O...
Brand Name : Ziagen
Dosage Strength : os soluz bottle 240 ml...
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
RLD : Yes
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : ZIAGEN
Dosage Strength : EQ 300MG BASE
Approval Date : 1998-12-17
Application Number : 20977
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code : AA
Dosage Form : SOLUTION; ORAL
Proprietary Name : ZIAGEN
Dosage Strength : EQ 20MG BASE/ML
Approval Date : 1998-12-17
Application Number : 20978
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AA
RLD : Yes
TE Code :
ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE
Dosage Form : TABLET; ORAL
Proprietary Name : TRIUMEQ
Dosage Strength : EQ 600MG BASE;EQ 50MG BA...
Approval Date : 2014-08-22
Application Number : 205551
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE
Dosage Form : TABLET, FOR SUSPENSION; ORAL
Proprietary Name : TRIUMEQ PD
Dosage Strength : EQ 60MG BASE;EQ 5MG BASE...
Approval Date : 2022-03-30
Application Number : 215413
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : EPZICOM
Dosage Strength : EQ 600MG BASE;300MG
Approval Date : 2004-08-02
Application Number : 21652
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE
Dosage Form : TABLET; ORAL
Proprietary Name : TRIZIVIR
Dosage Strength : EQ 300MG BASE;150MG;300M...
Approval Date : 2000-11-14
Application Number : 21205
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
ACETAMINOPHEN; ASPIRIN; CAFFEINE
Dosage Form : TABLET; ORAL
Proprietary Name : EXCEDRIN (MIGRAINE RELIE...
Dosage Strength : 250MG;250MG;65MG
Approval Date : 1998-01-14
Application Number : 20802
RX/OTC/DISCN : OTC
RLD : Yes
TE Code :
RLD : No
TE Code :
ACETAMINOPHEN; CODEINE PHOSPHATE
Dosage Form : TABLET; ORAL
Proprietary Name : EMPRACET W/ CODEINE PHOS...
Dosage Strength : 300MG;30MG
Approval Date : 1982-01-01
Application Number : 83951
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
ACETAMINOPHEN; CODEINE PHOSPHATE
Dosage Form : TABLET; ORAL
Proprietary Name : EMPRACET W/ CODEINE PHOS...
Dosage Strength : 300MG;60MG
Approval Date : 1982-01-01
Application Number : 83951
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : Yes
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : ADVIL DUAL ACTION WITH A...
Dosage Strength : 250MG;125MG
Approval Date : 2020-02-28
Application Number : 211733
RX/OTC/DISCN : OTC
RLD : Yes
TE Code :
Regulatory Info :
Registration Country : Switzerland
Dosage Form : Drinking Solution
Dosage Strength : 20mg/ml
Packaging :
Brand Name : Ziagen
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Dosage Form : Tabl
Dosage Strength : 300mg
Packaging :
Brand Name : Ziagen
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Italy
Dosage Form : Abacavir 20Mg/Ml 240Ml Oral Us...
Dosage Strength : os soluz bottle 240 ml 20 m...
Packaging :
Brand Name : Ziagen
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Dosage Form : Abacavir 300Mg 60 Units Oral U...
Dosage Strength : 60 cpr riv div 300 mg
Packaging :
Brand Name : Ziagen
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 300 mg
Packaging : Blister
Brand Name : Ziagen
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Sweden
Dosage Form : ORAL SOLUTION
Dosage Strength : 20 MG / ML
Packaging :
Brand Name : Ziagen
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Dosage Form : FILM COATED PILL
Dosage Strength : 300 MG
Packaging :
Brand Name : Ziagen
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Norway
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 300 mg/150 mg/300 mg
Packaging : Box
Brand Name : Trizivir
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 300 mg/150 mg/300 mg
Packaging : Blister
Brand Name : Trizivir
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Italy
Dosage Form : Abacavir+Lamivudine 600+300Mg ...
Dosage Strength : 30 cpr riv 600 mg + 300 mg
Packaging :
Brand Name : Kivexa
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info : Prescription
Registration Country : Canada
Dosage Form : SOLUTION
Dosage Strength : 20MG/ML
Packaging : 240 ML
Brand Name : ZIAGEN
Approval Date :
Application Number : 2240358
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Dosage Form : TABLET
Dosage Strength : 600MG
Packaging : 30
Brand Name : KIVEXA
Approval Date :
Application Number : 2269341
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Dosage Form : TABLET
Dosage Strength : 600MG
Packaging : 30
Brand Name : TRIUMEQ
Approval Date :
Application Number : 2430932
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : OTC
Registration Country : Canada
Dosage Form : POWDER FOR SOLUTION
Dosage Strength : 1000MG/SACHET
Packaging : 10
Brand Name : NEOCITRAN ULTRA STRENGTH TOTA...
Approval Date :
Application Number : 2217147
Regulatory Info : OTC
Registration Country : Canada
Regulatory Info : Narcotic (CDSA I)
Registration Country : Canada
Dosage Form : TABLET
Dosage Strength : 325MG
Packaging :
Brand Name : ROBAXACET-8
Approval Date :
Application Number : 1934767
Regulatory Info : Narcotic (CDSA I)
Registration Country : Canada
Regulatory Info : OTC
Registration Country : Canada
Dosage Form : KIT
Dosage Strength : 325MG
Packaging :
Brand Name : BUCKLEY'S COLD & SINUS 24 HOU...
Approval Date :
Application Number : 2493802
Regulatory Info : OTC
Registration Country : Canada
Regulatory Info : OTC
Registration Country : Canada
Dosage Form : CAPSULE
Dosage Strength : 325MG
Packaging :
Brand Name : BUCKLEY'S COMPLETE NIGHTTIME ...
Approval Date :
Application Number : 2335239
Regulatory Info : OTC
Registration Country : Canada
Regulatory Info : OTC
Registration Country : Canada
Dosage Form : CAPSULE
Dosage Strength : 250MG
Packaging :
Brand Name : BUCKLEY'S COMPLETE + MUCUS RE...
Approval Date :
Application Number : 2335948
Regulatory Info : OTC
Registration Country : Canada
Regulatory Info : OTC
Registration Country : Canada
Dosage Form : POWDER FOR SOLUTION
Dosage Strength : 650MG/SACHET
Packaging : 10
Brand Name : NEOCITRAN EXTRA STRENGTH COLD...
Approval Date :
Application Number : 2456982
Regulatory Info : OTC
Registration Country : Canada
Regulatory Info : OTC
Registration Country : Canada
Dosage Form : POWDER FOR SOLUTION
Dosage Strength : 1000MG/SACHET
Packaging : 10 PCK
Brand Name : NEOCITRAN ULTRA STRENGTH TOTA...
Approval Date :
Application Number : 2404966
Regulatory Info : OTC
Registration Country : Canada
Regulatory Info : Originator
Registration Country : South Africa
Dosage Form : INJ
Dosage Strength : 15ug
Packaging : 0.5X1ug
Brand Name : Fluarix Tetra
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
A/Michigan/45/2015 (H1N1) PDM09
Dosage Form : INJ
Dosage Strength : 15ug
Packaging : 0.5X1ug
Brand Name : Fluarix Tetra
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Dosage Form : TAB
Dosage Strength : 300mg
Packaging : 60X1mg
Brand Name : Trizivar
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Dosage Form : TAB
Dosage Strength : 600mg
Packaging : 30X1mg
Brand Name : Kivexa
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Dosage Form : TAB
Dosage Strength : 600mg
Packaging : 30X1mg
Brand Name : Trelavue
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Dosage Form : TAB
Dosage Strength : 300mg
Packaging : 60X1mg
Brand Name : Ziagen Tablets
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Dosage Form : SYR
Dosage Strength : 20mg/ml
Packaging : 240X1mg/ml
Brand Name : Ziagen Oral Solution
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Dosage Form : OIN
Dosage Strength : 30mg/g
Packaging : 4.5X1mg/g
Brand Name : Zovirax
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Dosage Form : INJ
Dosage Strength : 250mg
Packaging : 10X5mg
Brand Name : Zovirax IV
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Dosage Form : SUS
Dosage Strength : 200mg/5ml
Packaging : 125X1mg/5ml
Brand Name : Zovirax Suspension
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Excipients
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5770
Submission : 1985-04-08
Status : Inactive
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5770
Submission : 1985-04-08
Status : Inactive
Type : IV
Excipients Web Link
Inspections and registrations
Type : GMP Certificates
Number : BE/GMP/2016...
EudraGMDP Key : 8728
Country : U.S.A
Issue Date : 2016-03-10
Post Code : PA 17547
NCA Ref : 872812683896...
City : Marietta
Type : GMP Certificates
Number : 15MPP079HPT...
EudraGMDP Key : 39620
Country : Singapore
Issue Date : 2016-02-24
Post Code : 618809
NCA Ref : 396201456308...
City : Singapore
Type : GMP Certificates
Number : HPF/FR/50/2...
EudraGMDP Key : 39262
Country : France
Issue Date : 2016-02-24
Post Code : 27000
NCA Ref : 410352777000...
City : EVREUX
Type : GMP Certificates
Number : HPF/FR/49/2...
EudraGMDP Key : 39262
Country : France
Issue Date : 2016-02-24
Post Code : 27000
NCA Ref : 410352777000...
City : EVREUX
Type : GMP Certificates
Number : BE/2013/035
EudraGMDP Key : 8728
Country : U.S.A
Issue Date : 2015-12-21
Post Code : PA 17547
NCA Ref : 872812683896...
City : Marietta
Type : GMP Certificates
Number : DE_SH_01_GM...
EudraGMDP Key : 36597
Country : South Africa
Issue Date : 2015-11-05
Post Code : 7460
NCA Ref : 00023039
City : Cape Town
Type : GMP Certificates
Number : UK MIA(IMP)...
EudraGMDP Key : 6674
Country : United Kingdom
Issue Date : 2015-11-03
Post Code : DL12 8DT
NCA Ref : 3848-GLAXO O...
City : BARNARD CASTLE
Type : GMP Certificates
Number : UK MIA 4 In...
EudraGMDP Key : 6674
Country : United Kingdom
Issue Date : 2015-11-03
Post Code : DL12 8DT
NCA Ref : 3848-GLAXO O...
City : BARNARD CASTLE
Type : GMP Certificates
Number : UK ManA 4 I...
EudraGMDP Key : 6674
Country : United Kingdom
Issue Date : 2015-11-03
Post Code : DL12 8DT
NCA Ref : 3848-GLAXO O...
City : BARNARD CASTLE
Type : GMP Non-Compliance
Number : Insp GMP 28...
EudraGMDP Key : 11629
Country : China
Issue Date : 2015-10-23
Post Code : CN-300457
NCA Ref : 122298- GLAX...
City : TIANJIN
Name and address of WHO GMP certified Manufacturer : GLAXOSMITHKLINE ASIA PRIVATE LIMITED A 10/1, ADDITIONAL M.I.D.C. AREA, AMBAD PATHARDI BLOCK NASHIK 422010
Country : United Kingdom
Name and address of WHO GMP certified Manufacturer : GLAXOSMITHKLINE PHARMACEUTICALS LTD. A-10 ADDITIONAL M.I.D.C. INDUSTIRAL AREA, AMBAD-PATHARDI BLOCK NASHIK NASHIK 422010
Country : United Kingdom
API Manufacturer : API MANUFACTURE
FDF Manufacturer :
Facility Name : Beecham Pharmaceuticals (Pte) ...
Business Address : 38 Quality Road Jurong 61880...
FEI Number : 3003469490
Country : United Kingdom
Paid in : 2019
API Manufacturer :
FDF Manufacturer : FDF MANUFACTURE
Facility Name : GlaxoSmithKline Manufacturing ...
Business Address : Via Alessandro Fleming 2 Ver...
FEI Number : 3002807084
Country : United Kingdom
Paid in : 2019
API Manufacturer : API MANUFACTURE
FDF Manufacturer :
Facility Name : SmithKline Beecham LTD
Business Address : Shewalton Road Irvine Aryshi...
FEI Number : 3003723174
Country : United Kingdom
Paid in : 2019
ABOUT THIS PAGE
GSK is a supplier offers 120 products (APIs, Excipients or Intermediates).
Find a price of Cefuroxime Sodium bulk with DMF, CEP offered by GSK
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