Fulvestrant is a Intramuscular Injection in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc. The primary component is Fulvestrant.
| Product ID | 0781-3079_005e02bd-7b42-4f50-b3f9-1155bc6467b5 |
| NDC | 0781-3079 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Fulvestrant |
| Generic Name | Fulvestrant |
| Dosage Form | Injection |
| Route of Administration | INTRAMUSCULAR |
| Marketing Start Date | 2019-05-29 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA205935 |
| Labeler Name | Sandoz Inc |
| Substance Name | FULVESTRANT |
| Active Ingredient Strength | 50 mg/mL |
| Pharm Classes | Estrogen Receptor Antagonist [EPC], Estrogen Receptor Antagonists [MoA], Selective Estrogen Receptor Modulators [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2019-05-29 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA205935 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2019-05-29 |
| Marketing Category | ANDA |
| Application Number | ANDA205935 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2019-05-29 |
| SPL SET ID: | 29010790-9257-4f70-a5ca-64038f0cc504 |
| Manufacturer | |
| UNII |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0143-9022 | Fulvestrant | Fulvestrant |
| 0310-7720 | Fulvestrant | Fulvestrant |
| 0591-5019 | Fulvestrant | Fulvestrant |
| 0781-3079 | Fulvestrant | Fulvestrant |
| 0781-3492 | Fulvestrant | Fulvestrant |
| 16714-070 | FULVESTRANT | fulvestrant |
| 16714-118 | Fulvestrant | Fulvestrant |
| 16729-436 | FULVESTRANT | Fulvestrant |
| 25021-462 | fulvestrant | fulvestrant |
| 43598-262 | Fulvestrant | Fulvestrant |
| 70121-1463 | Fulvestrant | Fulvestrant |
| 63323-715 | Fulvestrant | Fulvestrant |
| 67457-311 | Fulvestrant | Fulvestrant |
| 68462-317 | Fulvestrant | Fulvestrant |
| 70534-002 | fulvestrant | fulvestrant |
| 68001-424 | fulvestrant | fulvestrant |
| 68842-301 | Fulvestrant | Fulvestrant |
| 70860-211 | Fulvestrant | Fulvestrant |
| 71288-555 | Fulvestrant | Fulvestrant |
| 71731-6121 | Fulvestrant | Fulvestrant |
| 72603-105 | Fulvestrant | Fulvestrant |
| 0310-0720 | FASLODEX | Fulvestrant |