| Product Information |
|
| Registration Number |
DRP-12929
|
| Generic Name |
Tramadol Hydrochloride
|
| Brand Name |
Saphtram
|
| Dosage Strength |
50 mg/mL (100mg/2mL)
|
| Dosage Form |
Solution For Injection (IM/IV)
|
| Classification |
Prescription Drug (Rx)
|
| Pharmacologic Category |
Opiod Analgesic
|
| Packaging |
USP Type I Glass ampoule (Box of 10 ampoules x 1 mL in PVC tray; Box of 10 ampoules x 2mL in PVC tray)
|
| Manufacturer |
Kilitch Drugs (1) Ltd.
|
| Country of Origin |
India
|
| Trader |
Sapphire Lifesciences Pvt. Ltd.
|
| Importer |
Nelpa Lifesciences, Inc.
|
| Distributor |
Nelpa Lifesciences, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
03 November 2022
|
| Expiry Date |
03 November 2027
|