FDA.report

Sandoz GmbH

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30048284733004828473Sandoz GmbH1N2020-04-25Biochemiestrasse 10 Langkampfen Tirol AT 6336

GUDID Contact Samples

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDIDProductPhoneEmail
47612799222849Omnitrope 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/8005258747medicalaffairs.us@sandoz.com
47612799222849Omnitrope 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/800-525-8747medicalaffairs.us@sandoz.com

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1700611472074239K124026LOBSTER AUTO-INJECTORKZH2013-09-13

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
KZH12013-09-13

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/

Sandoz GmbH

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/

Sandoz GmbH

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/

Sandoz GmbH

2023-02-07