ORRIS ROOT is a Percutaneous; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Allergy Laboratories, Inc.. The primary component is Iris Germanica Var. Florentina Root.
| Product ID | 54575-272_dbe7bebd-e445-4e59-8302-e706b795fbde |
| NDC | 54575-272 |
| Product Type | Human Prescription Drug |
| Proprietary Name | ORRIS ROOT |
| Generic Name | Iris Germanica Var. Florentina Root |
| Dosage Form | Injection, Solution |
| Route of Administration | PERCUTANEOUS; SUBCUTANEOUS |
| Marketing Start Date | 1967-12-07 |
| Marketing Category | BLA / BLA |
| Application Number | BLA101376 |
| Labeler Name | Allergy Laboratories, Inc. |
| Substance Name | IRIS GERMANICA VAR. FLORENTINA ROOT |
| Active Ingredient Strength | 1 g/20mL |
| Pharm Classes | Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2018-12-31 |
| Marketing Start Date | 1967-12-07 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | BLA |
| Application Number | BLA101376 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1967-12-07 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | BLA |
| Application Number | BLA101376 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1967-12-07 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | BLA |
| Application Number | BLA101376 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1967-12-07 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | BLA |
| Application Number | BLA101376 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1967-12-07 |
| Inactivation Date | 2020-01-31 |
| Ingredient | Strength |
|---|---|
| IRIS GERMANICA VAR. FLORENTINA ROOT | 1 g/20mL |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 22840-1530 | Orris Root | Iris germanica |
| 22840-1531 | Orris Root | Iris germanica |
| 22840-5515 | Orris Root | Iris germanica |
| 36987-2234 | Orris Root | Orris Root |
| 36987-2235 | Orris Root | Orris Root |
| 36987-2236 | Orris Root | Orris Root |
| 36987-2237 | Orris Root | Orris Root |
| 49288-0343 | Orris Root | Orris Root |
| 49288-0344 | Orris Root | Orris Root |
| 49643-020 | Orris Root | Orris Root |
| 54575-272 | ORRIS ROOT | iris germanica var. florentina root |