01 1LEO PHARMA AS
02 12PFIZER
03 2PHARMACIA AND UPJOHN
01 4INJECTABLE;INJECTION
02 11INJECTABLE;SUBCUTANEOUS
01 6DISCN
02 9RX
01 12FRAGMIN
02 1INNOHEP
03 2NORMIFLO
01 4No
02 11Yes
RLD : Yes
TE Code :
Brand Name : NORMIFLO
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 10,000 UNITS/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1997-05-23
Application Number : 20227
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : NORMIFLO
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 5,000 UNITS/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1997-05-23
Application Number : 20227
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : FRAGMIN
Dosage Form : INJECTABLE;SUBCUTANEOUS
Dosage Strength : 2,500IU/0.2ML (12,500IU/ML)
Approval Date : 1994-12-22
Application Number : 20287
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : No
TE Code :
Brand Name : FRAGMIN
Dosage Form : INJECTABLE;SUBCUTANEOUS
Dosage Strength : 10,000IU/0.4ML (25,000IU/ML)
Approval Date : 2007-05-01
Application Number : 20287
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : Yes
TE Code :
Brand Name : FRAGMIN
Dosage Form : INJECTABLE;SUBCUTANEOUS
Dosage Strength : 5,000IU/0.2ML (25,000IU/ML)
Approval Date : 1996-03-18
Application Number : 20287
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : FRAGMIN
Dosage Form : INJECTABLE;SUBCUTANEOUS
Dosage Strength : 10,000IU/ML (10,000IU/ML)
Approval Date : 1998-01-30
Application Number : 20287
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : FRAGMIN
Dosage Form : INJECTABLE;SUBCUTANEOUS
Dosage Strength : 7,500IU/0.3ML (25,000IU/ML)
Approval Date : 2002-04-04
Application Number : 20287
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : FRAGMIN
Dosage Form : INJECTABLE;SUBCUTANEOUS
Dosage Strength : 95,000IU/3.8ML (25,000IU/ML)
Approval Date : 2002-04-04
Application Number : 20287
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : No
TE Code :
Brand Name : FRAGMIN
Dosage Form : INJECTABLE;SUBCUTANEOUS
Dosage Strength : 95,000IU/9.5ML (10,000IU/ML)
Approval Date : 2002-04-04
Application Number : 20287
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : FRAGMIN
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 7,500 IU/0.75ML
Approval Date : 2002-04-04
Application Number : 20287
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
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