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Approved Drug Products of Biocon Limited listed in the FDA Orange Book. Original Data : FDA Website

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Fingolimod Hydrochloride

Pemetrexed

Rosuvastatin Calcium

Simvastatin

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CAPSULE;ORAL

INJECTABLE;INJECTION

POWDER;INTRAVENOUS

TABLET;ORAL

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100MG

10MG

20MG

40MG

500MG

5MG

80MG

EQ 0.5MG BASE

EQ 100MG BASE/VIAL

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RX

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CAPSULE; ORAL
EQ 0.5MG BASE
2019-12-04
207979
FINGOLIMOD HYDROCH...
RX
No
AB
INJECTABLE; INJECT...
100MG
208927
PEMETREXED
INJECTABLE; INJECT...
500MG
208927
PEMETREXED
POWDER; INTRAVENOU...
EQ 100MG BASE/VIAL
211090
PEMETREXED DISODIU...
TABLET; ORAL
5MG
2016-10-31
207752
ROSUVASTATIN CALCI...
RX
No
AB
TABLET; ORAL
10MG
2016-10-31
207752
ROSUVASTATIN CALCI...
RX
No
AB
TABLET; ORAL
20MG
2016-10-31
207752
ROSUVASTATIN CALCI...
RX
No
AB
TABLET; ORAL
40MG
2016-10-31
207752
ROSUVASTATIN CALCI...
RX
No
AB
TABLET; ORAL
5MG
2006-12-20
78034
SIMVASTATIN
RX
No
AB
TABLET; ORAL
10MG
2006-12-20
78034
SIMVASTATIN
RX
No
AB
TABLET; ORAL
20MG
2006-12-20
78034
SIMVASTATIN
RX
No
AB
TABLET; ORAL
40MG
2006-12-20
78034
SIMVASTATIN
RX
No
AB
TABLET; ORAL
80MG
2006-12-20
78034
SIMVASTATIN
RX
No
AB

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