FDA.reportPublic FDA data

MYLAN

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
11103151110315MYLAN PHARMACEUTICALS INC.1Y2026-01-013711 Collins Ferry Road Morgantown WV US 26505
96166743002806521MYLAN TEORANTA1N2026-01-01Inverin Co. Galway IE H91H336
30039051563007886374Mylan Pharmaceuticals Inc.1N2020-04-25150 INDUSTRIAL ROAD SAN CARLOS CA US 94070

GUDID Contact Samples#

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

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00303786986019Sodium Chloride Inhalation Solution, USP 0.9% 5mL - The single-use device is in a color coded unit blow fill sealed container with liquid contents as labeled for inhalation therapy. Thedevice contains no preservative and is sterile and pyrogen free. Primary DI number is for one carton of 100 vials, the lowest saleable unit. Each vial is not sold separately and is not intended to be separated from it's unit of sale.1-877-446-3679customer.service@mylan.com
00303786987894Sodium Chloride Inhalation Solution, USP, 0.9% 15 mL - The single-use device is in a color coded unit blow fill sealed container with liquid contents as labeled for inhalation therapy. The device contains no preservative and is sterile and pyrogen free. Primary DI number is for one carton of 50 vials, the lowest saleable unit. Each vial is not sold separately and is not intended to be separated from it's unit of sale.1-877-446-3679customer.service@mylan.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1765782030470079K972778DEY VIAL SODIUM CHLORIDE 3%CAF1997-10-08
2902661365513886K141384WHISPERJECT AUTOINJECTORKZH2014-09-12
1765781897613910K141384WHISPERJECT AUTOINJECTORKZH2014-09-12
2368281750849839
2902661752458230

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KZH22014-09-12
CAF11997-10-08

NDC#

Atenolol

Mylan Pharmaceuticals Inc.

atenolol

Atenolol

Mylan Pharmaceuticals Inc.

atenolol

Diazepam

Mylan Pharmaceuticals Inc.

diazepam

Diazepam

Mylan Pharmaceuticals Inc.

diazepam

200 records. Showing 1-40. Next

Applications#

219687

MYLAN PHARMACEUTICALS INC

216976

MYLAN PHARMACEUTICALS INC

215682

MYLAN PHARMACEUTICALS INC A VIATRIS CO

200 records. Showing 1-40. Next

GUDID#

Sodium Chloride Inhalation Solution, USP 10% 15mL - The 10% solutions are contained in a 15mL polyethylene vial. The vials have a tear-off top and a lower tab for displaying the lotnumber and expiration date. One side of the vial has pressure sensitive label and the other side is blank. The vials are supplied incartons of 50 vials. Primary DI number is for one carton of 50 vials, the lowest saleable unit. Each vial is not sold separately and isnot intended to be separated from it's unit of sale.

Mylan Pharmaceuticals Inc.

2016-12-12

Sodium Chloride Inhalation Solution, USP, 3% 15mL - The 3% solutions are contained in a 15mL polyethylene vial. The vials have a tear-off top and a lower tab for displaying the lot number and expiration date. One side of the vial has pressure sensitive label and the other side is blank. The vials are supplied in cartons of 50 vials.Primary DI number is for one carton of 50 vials, the lowest saleable unit. Each vial is not sold separately and is not intended to be separated from it's unit of sale.

Mylan Pharmaceuticals Inc.

2016-12-12