| Product Information |
|
| Registration Number |
DRP-4660-02
|
| Generic Name |
Methotrexate
|
| Brand Name |
Omari
|
| Dosage Strength |
25 mg/mL (50 mg/2 mL)
|
| Dosage Form |
Solution for Injection (I.M./I.V./Intrathecal)
|
| Classification |
Prescription Drug (Rx)
|
| Pharmacologic Category |
Antineoplastic (Cell Cycle-Specific Agent)
|
| Packaging |
3 mL USP Type I Amber Glass Vial with 20 mm Slotted Grey Butyl Rubber Stopper with White Flip-off Aluminum Seal / (Box of 1's)
|
| Manufacturer |
Khandelwal Laboratories Pvt. Ltd.
|
| Country of Origin |
India
|
| Trader |
|
| Importer |
Medethix, Inc.
|
| Distributor |
Kaufmann Pharma Inc.
|
| Application Type |
CLIDP Conversion
|
| Issuance Date |
27 September 2024
|
| Expiry Date |
06 September 2028
|