01 1ACCORD HLTHCARE
02 1APOTEX
03 1APOTEX INC
04 1AUROBINDO PHARMA
05 1AVET LIFESCIENCES
06 1CHEMI SPA
07 1COBALT LABS INC
08 1DR REDDYS LABS LTD
09 1EUGIA PHARMA
10 2HOFFMANN LA ROCHE
11 1MACLEODS PHARMS LTD
12 1MYLAN LABS LTD
13 1NANG KUANG PHARM CO
14 1NORVIUM BIOSCIENCE
15 1ORBION PHARMS
16 1ROCHE
17 1SUN PHARM
18 1SUN PHARM INDUSTRIES
19 1TEVA PARENTERAL
20 1WATSON LABS TEVA
01 1INJECTABLE; INJECTION
02 9INJECTABLE;INTRAVENOUS
03 1TABLET; ORAL
04 10TABLET;ORAL
01 9DISCN
02 10RX
03 2Blank
01 3BONIVA
02 18IBANDRONATE SODIUM
01 16No
02 3Yes
03 2Blank
RLD : No
TE Code :
Brand Name : IBANDRONATE SODIUM
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 150MG BASE
Approval Date : 2012-03-20
Application Number : 79003
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code : AB
Brand Name : IBANDRONATE SODIUM
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 150MG BASE
Approval Date : 2012-03-19
Application Number : 78948
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD :
TE Code :
Brand Name : IBANDRONATE SODIUM
Dosage Form : TABLET; ORAL
Dosage Strength : 2.5MG
Approval Date :
Application Number : 79002
RX/OTC/DISCN :
RLD :
TE Code :
RLD : Yes
TE Code :
Brand Name : BONIVA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2003-05-16
Application Number : 21455
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : BONIVA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2005-03-24
Application Number : 21455
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : BONIVA
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : EQ 3MG BASE/3ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2006-01-06
Application Number : 21858
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : No
TE Code : AB
Brand Name : IBANDRONATE SODIUM
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 150MG BASE
Approval Date : 2012-03-19
Application Number : 78998
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code :
Brand Name : IBANDRONATE SODIUM
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 150MG BASE
Approval Date : 2012-08-15
Application Number : 78996
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code : AB
Brand Name : IBANDRONATE SODIUM
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 150MG BASE
Approval Date : 2012-04-30
Application Number : 78997
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code :
Brand Name : IBANDRONATE SODIUM
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 150MG BASE
Approval Date : 2012-03-19
Application Number : 78995
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
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