| Product Information |
|
| Registration Number |
DRP-8245-01
|
| Generic Name |
Methotrexate
|
| Brand Name |
Pteribene
|
| Dosage Strength |
100 mg / mL (500 mg / 5 mL)
|
| Dosage Form |
Solution for Injection (IM/IV)
|
| Classification |
Prescription Drug (Rx)
|
| Pharmacologic Category |
Antineoplastic
|
| Packaging |
5 mL USP Type I, amber tubular glass vial, sealed with 20 mm grey bromobutyl plain rubber stopper, with 20 mm red aluminum flip-off seal / (Box of 1's)
|
| Manufacturer |
Celon Laboratories Private Limited
|
| Country of Origin |
India
|
| Trader |
|
| Importer |
I.E. Medica, Inc
|
| Distributor |
Medethix, Inc.
|
| Application Type |
CLIDP Conversion
|
| Issuance Date |
11 June 2024
|
| Expiry Date |
25 June 2027
|