NDC 36987-2633
American Elm
American Elm
American Elm is a Intradermal; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Nelco Laboratories, Inc.. The primary component is Ulmus Americana Pollen.
| Product ID | 36987-2633_2a72f629-5585-48e0-bd3f-7804035e57fb |
| NDC | 36987-2633 |
| 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 | 1972-08-29 |
| Marketing Category | BLA / BLA |
| Application Number | BLA102192 |
| Labeler Name | Nelco Laboratories, Inc. |
| Substance Name | ULMUS AMERICANA POLLEN |
| Active Ingredient Strength | 40000 [PNU]/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 36987-2633-1
5 mL in 1 VIAL, MULTI-DOSE (36987-2633-1)
| Marketing Start Date | 1972-08-29 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 36987-2633-3 [36987263303]
American Elm INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA102192 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1972-08-29 |
| Inactivation Date | 2019-10-21 |
NDC 36987-2633-4 [36987263304]
American Elm INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA102192 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1972-08-29 |
| Inactivation Date | 2019-10-21 |
NDC 36987-2633-2 [36987263302]
American Elm INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA102192 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1972-08-29 |
| Inactivation Date | 2019-10-21 |
NDC 36987-2633-1 [36987263301]
American Elm INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA102192 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1972-08-29 |
| Inactivation Date | 2019-10-21 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| ULMUS AMERICANA POLLEN | 40000 [PNU]/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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.