Molds, Rusts and Smuts, Pullularia pullulans is a Intradermal Injection, Solution in the Non-standardized Allergenic category. It is labeled and distributed by Jubilant Hollisterstier Llc. The primary component is Aureobasidium Pullulans Var. Pullutans.
| Product ID | 65044-5234_28a415a2-d591-4fbe-a3e3-2559dc4b1039 |
| NDC | 65044-5234 |
| Product Type | Non-standardized Allergenic |
| Proprietary Name | Molds, Rusts and Smuts, Pullularia pullulans |
| Generic Name | Pullularia Pullulans |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRADERMAL |
| Marketing Start Date | 1941-04-19 |
| Marketing Category | BLA / BLA |
| Application Number | BLA103888 |
| Labeler Name | Jubilant HollisterStier LLC |
| Substance Name | AUREOBASIDIUM PULLULANS VAR. PULLUTANS |
| Active Ingredient Strength | 1000 [PNU]/mL |
| Pharm Classes | Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 1941-04-19 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | BLA |
| Application Number | BLA103888 |
| Product Type | NON-STANDARDIZED ALLERGENIC |
| Marketing Start Date | 1941-04-19 |
| Inactivation Date | 2020-01-31 |
| Ingredient | Strength |
|---|---|
| AUREOBASIDIUM PULLULANS VAR. PULLUTANS | 1000 [PNU]/mL |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 65044-5233 | Molds, Rusts and Smuts, Pullularia pullulans | Pullularia pullulans |
| 65044-5234 | Molds, Rusts and Smuts, Pullularia pullulans | Pullularia pullulans |
| 65044-5235 | Molds, Rusts and Smuts, Pullularia pullulans | Pullularia pullulans |
| 0268-0832 | AUREOBASIDIUM PULLULANS VAR PULLULANS | PULLULARIA PULLULANS |
| 0268-0833 | AUREOBASIDIUM PULLULANS VAR PULLULANS | PULLULARIA PULLULANS |
| 0268-0834 | AUREOBASIDIUM PULLULANS VAR PULLULANS | PULLULARIA PULLULANS |
| 0268-0835 | AUREOBASIDIUM PULLULANS VAR PULLULANS | PULLULARIA PULLULANS |
| 0268-0836 | AUREOBASIDIUM PULLULANS VAR PULLULANS | PULLULARIA PULLULANS |
| 0268-6509 | AUREOBASIDIUM PULLULANS VAR PULLULANS | PULLULARIA PULLULANS |
| 49643-117 | Pullularia | Pullularia pullulans |