NDC 49288-0191
American Elm
American Elm
American Elm is a Intradermal; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Antigen Laboratories, Inc.. The primary component is Ulmus Americana Pollen.
| Product ID | 49288-0191_13c9eea1-38b5-472b-b735-a814ca886718 |
| NDC | 49288-0191 |
| Product Type | Human Prescription Drug |
| Proprietary Name | American Elm |
| Generic Name | American Elm |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRADERMAL; SUBCUTANEOUS |
| Marketing Start Date | 1974-03-23 |
| Marketing Category | BLA / BLA |
| Application Number | BLA102223 |
| Labeler Name | Antigen Laboratories, Inc. |
| Substance Name | ULMUS AMERICANA POLLEN |
| Active Ingredient Strength | 0 g/mL |
| Pharm Classes | Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2017-12-31 |
Packaging
NDC 49288-0191-1
2 mL in 1 VIAL, MULTI-DOSE (49288-0191-1)
| Marketing Start Date | 1974-03-23 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 49288-0191-1 [49288019101]
American Elm INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA102223 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1974-03-23 |
| Inactivation Date | 2019-10-21 |
NDC 49288-0191-5 [49288019105]
American Elm INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA102223 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1974-03-23 |
| Inactivation Date | 2019-10-21 |
NDC 49288-0191-3 [49288019103]
American Elm INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA102223 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1974-03-23 |
| Inactivation Date | 2019-10-21 |
NDC 49288-0191-2 [49288019102]
American Elm INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA102223 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1974-03-23 |
| Inactivation Date | 2019-10-21 |
NDC 49288-0191-4 [49288019104]
American Elm INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA102223 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1974-03-23 |
| Inactivation Date | 2019-10-21 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| ULMUS AMERICANA POLLEN | .05 g/mL |
OpenFDA Data
Pharmacological Class
- Non-Standardized Pollen Allergenic Extract [EPC]
- Increased Histamine Release [PE]
- Cell-mediated Immunity [PE]
- Increased IgG Production [PE]
- Pollen [CS]
- Allergens [CS]
NDC Crossover Matching brand name "American Elm" or generic name "American Elm"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 36987-2629 | American Elm | American Elm |
| 36987-2630 | American Elm | American Elm |
| 36987-2631 | American Elm | American Elm |
| 36987-2632 | American Elm | American Elm |
| 36987-2633 | American Elm | American Elm |
| 36987-2634 | American Elm | American Elm |
| 36987-2635 | American Elm | American Elm |
| 36987-2636 | American Elm | American Elm |
| 49288-0190 | American Elm | American Elm |
| 49288-0191 | American Elm | American Elm |
| 0268-6623 | ULMUS AMERICANA POLLEN | American Elm |
| 0268-6708 | ULMUS AMERICANA POLLEN | American Elm |
Trademark Results [American Elm]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AMERICAN ELM 97589289 not registered Live/Pending |
PCF Insurance Services of the West, LLC 2022-09-13 |
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