اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
ASTEPRO ALLERGY از شرکت BAYER HLTHCARE
New Drug Application (NDA): 213872
Company: BAYER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ASTEPRO ALLERGY | AZELASTINE HYDROCHLORIDE | 0.2055MG/SPRAY | SPRAY, METERED;NASAL | Over-the-counter |
None |
Yes | Yes |
| CHILDREN’S ASTEPRO ALLERGY | AZELASTINE HYDROCHLORIDE | 0.2055MG/SPRAY | SPRAY, METERED;NASAL | Over-the-counter |
None |
Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/17/2021 | ORIG-1 | Approval |
Type 8 – Partial Rx to OTC Switch |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213872Orig1s000Lbl.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/17/2021 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213872Orig1s000Lbl.pdf |
ASTEPRO ALLERGY
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SPRAY, METERED;NASAL; 0.2055MG/SPRAY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| ASTEPRO ALLERGY | AZELASTINE HYDROCHLORIDE | 0.2055MG/SPRAY | SPRAY, METERED;NASAL | Over-the-counter | Yes | 213872 | BAYER HLTHCARE |
| CHILDREN’S ASTEPRO ALLERGY | AZELASTINE HYDROCHLORIDE | 0.2055MG/SPRAY | SPRAY, METERED;NASAL | Over-the-counter | Yes | 213872 | BAYER HLTHCARE |
CHILDREN’S ASTEPRO ALLERGY
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SPRAY, METERED;NASAL; 0.2055MG/SPRAY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| ASTEPRO ALLERGY | AZELASTINE HYDROCHLORIDE | 0.2055MG/SPRAY | SPRAY, METERED;NASAL | Over-the-counter | Yes | 213872 | BAYER HLTHCARE |
| CHILDREN’S ASTEPRO ALLERGY | AZELASTINE HYDROCHLORIDE | 0.2055MG/SPRAY | SPRAY, METERED;NASAL | Over-the-counter | Yes | 213872 | BAYER HLTHCARE |
نظرات کاربران