sandoz.comGlatopaject® - The Glatopaject® is a reusable injection device for the subcutaneous injection of Glatopa®. The Glatopaject® is intended for use with Glatopa® (Glatiramer Acetate Injection) Pre-Filled Syringe.
2016-11-21
Sandoz GmbH
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3004828473 | 3004828473 | Sandoz GmbH | 1 | N | 2020-04-25 | Biochemiestrasse 10 Langkampfen Tirol AT 6336 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 47612799222849 | Omnitrope Pen 5 - The Omnitrope Pen 5 is a reusable injection pen for use with Omnitrope cartridges. Omnitrope Pen from BD is intended for subcutaneous injection of a daily dose of Omnitrope (rhGH drug). It is intended for patients (pediatric and adults) treated for growth disturbances and growth hormone deficiencies. The injection can be performed by the patient him/herself or also by a trained caregiver in case of small children or patient unable to perform the injection themselves. For information on the use of Omnitrope 5, see: http://www.omnitope.com/getting-started/injection-training/ | 8005258747 | medicalaffairs.us@sandoz.com |
| 47612799222849 | Omnitrope Pen 5 - The Omnitrope Pen 5 is a reusable injection pen for use with Omnitrope cartridges. Omnitrope Pen from BD is intended for subcutaneous injection of a daily dose of Omnitrope (rhGH drug). It is intended for patients (pediatric and adults) treated for growth disturbances and growth hormone deficiencies. The injection can be performed by the patient him/herself or also by a trained caregiver in case of small children or patient unable to perform the injection themselves. For information on the use of Omnitrope 5, see: http://www.omnitope.com/getting-started/injection-training/ | 800-525-8747 | medicalaffairs.us@sandoz.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 170061 | 1472074239 | K124026 | LOBSTER AUTO-INJECTOR | KZH | 2013-09-13 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| KZH | 1 | 2013-09-13 |
GUDID#
Omnitrope Pen 10 - The Omnitrope Pen 10 is a reusable injection pen for use with Omnitrope cartridges. Omnitrope Pen from BD is intended for subcutaneous injection of a daily dose of Omnitrope (rhGH drug). It is intended for patients (pediatric patients and adults) treated for growth disturbances and growth hormone deficiencies. The injection can be performed by the patient him/herself or also by a trained caregiver in case of small children or patients unable to perform the injection themselves. For information on the use of Omnitrope Pen 10, see:http://www.omnitrope.com/getting-started/injection-training/
2023-02-07
Omnitrope Pen 5 - The Omnitrope Pen 5 is a reusable injection pen for use with Omnitrope cartridges. Omnitrope Pen from BD is intended for subcutaneous injection of a daily dose of Omnitrope (rhGH drug). It is intended for patients (pediatric patients and adults) treated for growth disturbances and growth hormone deficiencies. The injection can be performed by the patient him/herself or also by a trained caregiver in case of small children or patients unable to perform the injection themselves. For information on the use of Omnitrope Pen 5, see:http://www.omnitrope.com/getting-started/injection-training/
2023-02-07
Omnitrope Pen 10 - The Omnitrope Pen 10 is a reusable injection pen for use with Omnitrope cartridges. Omnitrope Pen from BD is intended for subcutaneous injection of a daily dose of Omnitrope (rhGH drug). It is intended for patients (pediatric patients and adults) treated for growth disturbances and growth hormone deficiencies. The injection can be performed by the patient him/herself or also by a trained caregiver in case of small children or patients unable to perform the injection themselves. For information on the use of Omnitrope Pen 10, see: http://www.omnitrope.com/getting-started/injection-training/
2023-02-07
Omnitrope Pen 5 - The Omnitrope Pen 5 is a reusable injection pen for use with Omnitrope cartridges. Omnitrope Pen from BD is intended for subcutaneous injection of a daily dose of Omnitrope (rhGH drug). It is intended for patients (pediatric and adults) treated for growth disturbances and growth hormone deficiencies. The injection can be performed by the patient him/herself or also by a trained caregiver in case of small children or patient unable to perform the injection themselves. For information on the use of Omnitrope 5, see: http://www.omnitope.com/getting-started/injection-training/
2023-02-07
Omnitrope Pen 10 - The Omnitrope Pen 10 is a reusable injection pen for use with Omnitrope cartridges. Omnitrope Pen from BD is intended for subcutaneous injection of a daily dose of Omnitrope (rhGH drug). It is intended for patients (pediatric and adults) treated for growth disturbances and growth hormone deficiencies. The injection can be performed by the patient him/herself or also by a trained caregiver in case of small children or patient unable to perform the injection themselves. For information on the use of Omnitrope 10, see: http://www.omnitope.com/getting-started/injection-training/
2023-02-07
Glatopaject® - The Glatopaject® is a reusable injection device for the subcutaneous injection of Glatopa®. The Glatopaject® is intended for use with Glatopa® (Glatir
2016-11-21