| Product Information |
|
| Registration Number |
BRP-054-02
|
| Generic Name |
Biphasic Isophane Insulin Human (Recombinant DNA Origin)
|
| Brand Name |
None
|
| Dosage Strength |
100 IU/mL
|
| Dosage Form |
Suspension for Injection (SC) (30% Regular Insulin Human/70% Isophane Insulin Human)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Intermediate-Acting Insulin
|
| Packaging |
USP Type I clear and colourless glass cartridge x 3 mL (Box of 1's)
|
| Manufacturer |
Wockhardt Limited
|
| Country of Origin |
India
|
| Trader |
|
| Importer |
Ambica International Corporation
|
| Distributor |
Ambicare Pharmaceuticals Inc.
|
| Application Type |
Automatic Renewal (E-AR)
|
| Issuance Date |
15 November 2023
|
| Expiry Date |
10 February 2029
|