| Product Information |
|
| Registration Number |
DRP-13158
|
| Generic Name |
Fulvestrant
|
| Brand Name |
Fulvetrant
|
| Dosage Strength |
50 mg/mL (250mg/5mL)
|
| Dosage Form |
Solution For Injection (IM)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Anti-estrogen
|
| Packaging |
5 mL Pre-filled Syringe consisting of USP Type I Siliconized neutral glass with Elastomeric Plunger Stopper + 5 mL Polystyrene, crystal plunger rod and 5 mL Polypropylene made back stop + 21 G x 1 1/2 TW Sterile safety glide needle (Box of 2's)
|
| Manufacturer |
Sun Pharmaceutical Industries Ltd
|
| Country of Origin |
India
|
| Trader |
N/A
|
| Importer |
Sun Pharma Philippines, Inc.
|
| Distributor |
Sun Pharma Philippines, Inc.
|
| Application Type |
Initial (Reconstruction)
|
| Issuance Date |
31 July 2024
|
| Expiry Date |
12 December 2027
|