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methotrexate
MYLAN
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1110315 | 1110315 | MYLAN PHARMACEUTICALS INC. | 1 | Y | 2026-01-01 | 3711 Collins Ferry Road Morgantown WV US 26505 |
| 9616674 | 3002806521 | MYLAN TEORANTA | 1 | N | 2026-01-01 | Inverin Co. Galway IE H91H336 |
| 3003905156 | 3007886374 | Mylan Pharmaceuticals Inc. | 1 | N | 2020-04-25 | 150 INDUSTRIAL ROAD SAN CARLOS CA US 94070 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00303786986019 | Sodium 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. | 1-877-446-3679 | customer.service@mylan.com |
| 00303786987894 | Sodium 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. | 1-877-446-3679 | customer.service@mylan.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 176578 | 2030470079 | K972778 | DEY VIAL SODIUM CHLORIDE 3% | CAF | 1997-10-08 |
| 290266 | 1365513886 | K141384 | WHISPERJECT AUTOINJECTOR | KZH | 2014-09-12 |
| 176578 | 1897613910 | K141384 | WHISPERJECT AUTOINJECTOR | KZH | 2014-09-12 |
| 236828 | 1750849839 | ||||
| 290266 | 1752458230 |
Product Codes Associated With Registrations#
NDC#
Metoprolol Tartrate
metoprolol tartrate
Metoprolol Tartrate
metoprolol tartrate
Perphenazine and Amitriptyline Hydrochloride
perphenazine and amitriptyline hydrochloride
Metoprolol Tartrate
metoprolol tartrate
Cimetidine
cimetidine
Perphenazine and Amitriptyline Hydrochloride
perphenazine and amitriptyline hydrochloride
Carbidopa and Levodopa
carbidopa and levodopa
Carbidopa and Levodopa
carbidopa and levodopa
Allopurinol
allopurinol
Tamoxifen Citrate
Tamoxifen Citrate
Allopurinol
allopurinol
Propranolol Hydrochloride
propranolol hydrochloride
Propranolol Hydrochloride
propranolol hydrochloride
Propranolol Hydrochloride
propranolol hydrochloride
Propranolol Hydrochloride
propranolol hydrochloride
Propranolol Hydrochloride
propranolol hydrochloride
Chlordiazepoxide and Amitriptyline Hydrochloride
chlordiazepoxide and amitriptyline hydrochloride
Chlorthalidone
chlorthalidone
Haloperidol
haloperidol
Atenolol
atenolol
Timolol Maleate
timolol maleate
Chlorthalidone
chlorthalidone
Atenolol
atenolol
Spironolactone
spironolactone
Haloperidol
haloperidol
Dabigatran Etexilate
Dabigatran Etexilate
Dabigatran Etexilate
Dabigatran Etexilate
Diazepam
diazepam
Tamoxifen Citrate
Tamoxifen Citrate
Chlordiazepoxide and Amitriptyline Hydrochloride
chlordiazepoxide and amitriptyline hydrochloride
Cimetidine
cimetidine
Haloperidol
haloperidol
Perphenazine and Amitriptyline Hydrochloride
perphenazine and amitriptyline hydrochloride
Haloperidol
haloperidol
Diazepam
diazepam
Haloperidol
haloperidol
Cimetidine
cimetidine
Spironolactone and Hydrochlorothiazide
spironolactone and hydrochlorothiazide
Metoprolol Tartrate and Hydrochlorothiazide
metoprolol tartrate and hydrochlorothiazide
Applications#
GUDID#
Whisperject - The WhisperJECT autoinjector is a non-sterile injection device. It is intended to be used with FDA approved drug products with non-viscous (aqueous) liquid formulations, which are presented in a 1.0 mL pre-filled glass syringe with staked needles. It is a reusable injection device for the subcutaneous injection of FDA approved drugs.
2018-03-19
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.
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.
2016-12-12
Sodium 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.
2016-12-12
Sodium 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.
2016-12-13
Sodium Chloride Inhalation Solution, USP, 0.9% 3mL UDV - 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.
2016-12-13
Easivent Mask - Large - The easivent mask is a mask attachment for a Metered Dose Inhaler Spacer. The mask fits directly onto the MDI spacer. The mask is a single piece, injection molded, silicone rubber piece.
2018-04-10
Easivent Mask - Medium - The easivent mask is a mask attachment for a Metered Dose Inhaler Spacer. The mask fits directly onto the MDI spacer. The mask is a single piece, injection molded, silicone rubber piece.
2018-04-10
Easivent Mask - Small - The easivent mask is a mask attachment for a Metered Dose Inhaler Spacer. The mask fits directly onto the MDI spacer. The mask is a single piece, injection molded, silicone rubber piece.
2018-04-10
EasiVENT Valved Holding Chamber - Easivent Valved Holding Chamber is designed to assist with Metered Dose Inhaler (MDI) aerosol medication delivery. It is comprised of a MDI adapter port, Holding chamber, a one way valve, Mouth Piece and mouthpiece cap
2018-04-10
Ace Aerosol Cloud Enhancer - The Aerosol Cloud Enhancer is designed to permit use in a vent circuit, an inceptive spirometer, in conjuction with an endotracheal airway or resuscitation bag and in routine oral inhalation. It has a coneshaped chamber intended to maximize respirable volume. The ACE masks attach and detach easily for MDI delivery.
2018-04-10
Easivent Mask - Small - The easivent mask is a mask attachment for a Metered Dose Inhaler Spacer. The mask fits directly onto the MDI spacer. The mask is a single piece, injection molded, silicone rubber piece.
2018-04-10
EasiVENT Valved Holding Chamber - Easivent Valved Holding Chamber is designed to assist with Metered Dose Inhaler (MDI) aerosol medication delivery. It is comprised of a MDI adapter port, Holding chamber, a one way valve, Mouth Piece and mouthpiece cap
2018-04-10
Ace Aerosol Cloud Enhancer - The Aerosol Cloud Enhancer is designed to permit use in a vent circuit, an inceptive spirometer, in conjuction with an endotracheal airway or resuscitation bag and in routine oral inhalation. It has a coneshaped chamber intended to maximize respirable volume. The ACE masks attach and detach easily for MDI delivery.
2018-04-10