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Approved Drug Products of EMD Serono listed in the FDA Orange Book. Original Data : FDA Website

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EMD Serono
United_States_of_America Flag
Country
Country
U.S.A
Address
Address
One Technology Place, Rockland, MA 02370
Telephone
Telephone
+18002838088

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INJECTABLE; INJECT...
20MG/ML
761049
BAVENCIO
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INJECTABLE; INTRAV...
20MG/ML
761078
BAVENCIO
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POWDER; SUBCUTANEO...
EQ 0.25MG BASE/VIA...
2000-08-11
21197
CETROTIDE
RX
Yes
AP
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POWDER; SUBCUTANEO...
EQ 3MG BASE/VIAL
2000-08-11
21197
CETROTIDE
DISCN
Yes
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INJECTABLE; INJECT...
0.25MG/VIAL
21149
OVIDREL
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INJECTABLE; SUBCUT...
EQ 0.25MG /0.5ML
21149
OVIDREL
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TABLET; ORAL
10MG
2019-03-29
22561
MAVENCLAD
RX
Yes
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TABLET; ORAL
50MG
1982-03-22
18361
SEROPHENE
DISCN
No
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URL Supplier Web Content
INJECTABLE; SUBCUT...
75 IU/VIAL
20378
GONAL-F
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URL Supplier Web Content
INJECTABLE; SUBCUT...
150 IU/VIAL
20378
GONAL-F
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URL Supplier Web Content
INJECTABLE; SUBCUT...
37.5 IU/VIAL
20378
GONAL-F
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INJECTABLE; SUBCUT...
1,050 IU/VIAL
20378
GONAL-F
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URL Supplier Web Content
INJECTABLE; SUBCUT...
450 IU/VIAL
20378
GONAL-F
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INJECTABLE; SUBCUT...
300 IU/0.5ML
21684
GONAL-F RFF REDI-J...
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INJECTABLE; SUBCUT...
450 IU/0.75ML
21684
GONAL-F RFF REDI-J...
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INJECTABLE; SUBCUT...
900 IU/1.5ML
21684
GONAL-F RFF REDI-J...
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INJECTABLE; SUBCUT...
150 IU/0.25ML
21684
GONAL-F RFF REDI-J...
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INJECTABLE; SUBCUT...
37.5 IU/VIAL
21765
GONAL-F
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INJECTABLE; SUBCUT...
75 IU/VIAL
21765
GONAL-F RFF
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INJECTABLE; SUBCUT...
150 IU/VIAL
21765
GONAL-F
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TABLET; ORAL
0.025MG
2005-06-16
76752
LEVOTHYROXINE SODI...
DISCN
No
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TABLET; ORAL
0.05MG
2005-06-16
76752
LEVOTHYROXINE SODI...
DISCN
No
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TABLET; ORAL
0.075MG
2005-06-16
76752
LEVOTHYROXINE SODI...
DISCN
No
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TABLET; ORAL
0.088MG
2005-06-16
76752
LEVOTHYROXINE SODI...
DISCN
No
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TABLET; ORAL
0.1MG
2005-06-16
76752
LEVOTHYROXINE SODI...
DISCN
No
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TABLET; ORAL
0.112MG
2005-06-16
76752
LEVOTHYROXINE SODI...
DISCN
No
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TABLET; ORAL
0.125MG
2005-06-16
76752
LEVOTHYROXINE SODI...
DISCN
No
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TABLET; ORAL
0.15MG
2005-06-16
76752
LEVOTHYROXINE SODI...
DISCN
No
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TABLET; ORAL
0.175MG
2005-06-16
76752
LEVOTHYROXINE SODI...
DISCN
No
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TABLET; ORAL
0.2MG
2005-06-16
76752
LEVOTHYROXINE SODI...
DISCN
No
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TABLET; ORAL
0.3MG
2005-06-16
76752
LEVOTHYROXINE SODI...
DISCN
No
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TABLET; ORAL
500MG **Federal Re...
1995-03-03
20357
GLUCOPHAGE
DISCN
Yes
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TABLET; ORAL
850MG **Federal Re...
1995-03-03
20357
GLUCOPHAGE
DISCN
Yes
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TABLET; ORAL
625MG **Federal Re...
1998-11-05
20357
GLUCOPHAGE
DISCN
Yes
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TABLET; ORAL
750MG **Federal Re...
1998-11-05
20357
GLUCOPHAGE
DISCN
Yes
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TABLET; ORAL
1GM **Federal Regi...
1998-11-05
20357
GLUCOPHAGE
DISCN
Yes
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TABLET, EXTENDED R...
500MG **Federal Re...
2000-10-13
21202
GLUCOPHAGE XR
DISCN
Yes
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TABLET, EXTENDED R...
750MG **Federal Re...
2003-04-11
21202
GLUCOPHAGE XR
DISCN
Yes
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INJECTABLE; INJECT...
EQ 20MG BASE/10ML ...
1987-12-23
19297
NOVANTRONE
DISCN
Yes
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INJECTABLE; INJECT...
EQ 25MG BASE/12.5M...
1987-12-23
19297
NOVANTRONE
DISCN
Yes
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INJECTABLE; INJECT...
EQ 30MG BASE/15ML ...
1987-12-23
19297
NOVANTRONE
DISCN
Yes
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INJECTABLE; INJECT...
EQ 0.05MG BASE/AMP...
1990-12-28
19863
GEREF
DISCN
Yes
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INJECTABLE; INJECT...
EQ 0.5MG BASE/VIAL...
1997-09-26
20443
GEREF
DISCN
Yes
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INJECTABLE; INJECT...
EQ 1MG BASE/VIAL *...
1997-09-26
20443
GEREF
DISCN
Yes
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INJECTABLE; INJECT...
6MG/VIAL
19764
SAIZEN
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INJECTABLE; INJECT...
6MG/VIAL
20604
SEROSTIM
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INJECTABLE; INJECT...
5MG/VIAL
20604
SEROSTIM
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INJECTABLE; INJECT...
4MG/VIAL
20604
SEROSTIM
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INJECTABLE; INJECT...
8.8MG/VIAL
20604
SEROSTIM
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INJECTABLE; SUBCUT...
6MG/0.5ML (6MG/0.5...
20604
SEROSTIM LQ
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