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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Biotika A.s.

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PENICILLIN G POTASSIUM

PENICILLIN G PROCAINE

PENICILLIN V POTASSIUM

POLYMYXIN B SULFATE

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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
PENICILLIN G POTASSIUM
Issue/Submission Date
2003-09-15
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
PENICILLIN G POTASSIUM
Issue/Submission Date
2003-09-15
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
PENICILLIN G PROCAINE
Issue/Submission Date
1999-09-10
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
PENICILLIN G PROCAINE
Issue/Submission Date
1999-09-10
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
PENICILLIN V POTASSIUM
Issue/Submission Date
1999-01-29
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Phenoxymethylpenicillin potassium
Issue/Submission Date
2008-02-08
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Filing Details
PENICILLIN V POTASSIUM
Phenoxymethylpenicillin potassium
Issue/Submission Date
1999-01-29
2008-02-08
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
POLYMYXIN B SULFATE
Issue/Submission Date
2010-05-31
Supporting Info

CEP/COS

Application Number
Status
VALID
Filing Details
Polymyxin B sulfate Micronised
Issue/Submission Date
2017-12-20
Supporting Info

Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info

Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Filing Details
POLYMYXIN B SULFATE
Polymyxin B sulfate Micronised
Issue/Submission Date
2010-05-31
2017-12-20
Supporting Info

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