| Product Information |
|
| Registration Number |
DRP-12161
|
| Generic Name |
Tigecycline
|
| Brand Name |
Saphcycline
|
| Dosage Strength |
50 mg
|
| Dosage Form |
Lyophilized Powder for Injection (I.V. Infusion)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Antibacterial (Tetracycline)
|
| Packaging |
USP Type I clear glass vial X 5 mL with grey bromobutyl rubber stopper and aluminum flip-off seal (Box of l’s and 10's)
|
| Manufacturer |
Kilitch Drugs (India) Ltd.
|
| Country of Origin |
India
|
| Trader |
|
| Importer |
Nelpa Lifesciences, Inc.
|
| Distributor |
Nelpa Lifesciences, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
29 June 2022
|
| Expiry Date |
29 June 2027
|