Thyrogen
THYROTROPIN ALFA
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1220423 | 1220423 | GENZYME CORPORATION | 1 | N | 2026-01-01 | 76 NEW YORK AVENUE FRAMINGHAM MA US 01701 |
| 3039908023 | 3039908023 | GENZYME CORPORATION | 1 | N | 2026-01-01 | 1125 PLEASANTVIEW TERRACE Ridgefield NJ US 07657 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00358468430120 | Seprafilm® - Barrier, Absorbable, Adhesion | +1(508)271-3304 | paul.dawidczykjr@genzyme.com |
| 00358468430120 | Seprafilm® - Barrier, Absorbable, Adhesion | +1(508)661-1471 | brian.nelson@genzyme.com |
| 00358468508621 | Seprafilm® Procedure Pack - Barrier, Absorbable, Adhesion | +1(508)661-1471 | brian.nelson@genzyme.com |
| 00358468508621 | Seprafilm® Procedure Pack - Barrier, Absorbable, Adhesion | +1(508)271-3304 | paul.dawidczykjr@genzyme.com |
| 00358468638014 | Seprafilm® 4-section - Barrier, Absorbable, Adhesion | +1(508)661-1471 | brian.nelson@genzyme.com |
| 00358468638014 | Seprafilm® 4-section - Barrier, Absorbable, Adhesion | +1(508)271-3304 | paul.dawidczykjr@genzyme.com |
| 00358468664112 | Seprafilm® Single Site - Barrier, Absorbable, Adhesion | +1(508)661-1471 | brian.nelson@genzyme.com |
| 00358468664112 | Seprafilm® Single Site - Barrier, Absorbable, Adhesion | +1(508)271-3304 | paul.dawidczykjr@genzyme.com |
| 00358468664211 | Seprafilm® Small Incision - Barrier, Absorbable, Adhesion | +1(508)661-1471 | brian.nelson@genzyme.com |
| 00358468664211 | Seprafilm® Small Incision - Barrier, Absorbable, Adhesion | +1(508)271-3304 | paul.dawidczykjr@genzyme.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 43413 | 1988041851 | P950034 | SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE | MCN | 1996-08-12 |
| 12349 | 1290652414 | P940015 | SYNVISC ONE | MOZ | 1997-08-08 |
| 43413 | 1685288049 | ||||
| 43413 | 1988041851 |
THYROTROPIN ALFA
AGALSIDASE BETA
AGALSIDASE BETA
olipudase alfa-rpcp
olipudase alfa-rpcp
laronidase
Anti-thymocyte Globulin (Rabbit)
SEVELAMER CARBONATE
SEVELAMER CARBONATE
SEVELAMER CARBONATE
ALGLUCOSIDASE ALFA
ALEMTUZUMAB
teriflunomide
teriflunomide
eliglustat
caplacizumab
rilzabrutinib
fitusiran
fitusiran
ALEMTUZUMAB
avalglucosidase alfa-ngpt
IMIGLUCERASE
Vandetanib
Vandetanib
GENZYME CORPORATION
GENZYME CORPORATION
GENZYME CORPORATION
GENZYME CORPORATION
GENZYME CORPORATION
GENZYME CORPORATION
2014-09-24
2014-09-24
2014-09-24
2014-09-24
2014-09-24
2022-10-19
2020-07-01
2020-07-01
2020-06-01
2020-06-01
2020-06-01
2020-06-01
2014-09-24
2014-09-25
2014-09-24
2014-09-24