Azelastine Hydrochloride is a Intraocular Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Gland Pharma Limited. The primary component is Azelastine Hydrochloride.
| Product ID | 68083-287_1d3aa46c-c96c-4a67-b2e1-0a4551bc1b15 |
| NDC | 68083-287 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Azelastine Hydrochloride |
| Generic Name | Azelastine Hydrochloride |
| Dosage Form | Solution/ Drops |
| Route of Administration | INTRAOCULAR |
| Marketing Start Date | 2020-02-25 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA210092 |
| Labeler Name | Gland Pharma Limited |
| Substance Name | AZELASTINE HYDROCHLORIDE |
| Active Ingredient Strength | 1 mg/mL |
| Pharm Classes | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2020-02-25 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA210092 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2020-02-25 |
| Ingredient | Strength |
|---|---|
| AZELASTINE HYDROCHLORIDE | .5 mg/mL |
| SPL SET ID: | f358cecd-284f-4d0b-806c-039465220bd2 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0054-0293 | Azelastine Hydrochloride | Azelastine Hydrochloride |
| 0832-0290 | Azelastine Hydrochloride | Azelastine Hydrochloride |
| 17478-718 | Azelastine Hydrochloride | Azelastine Hydrochloride |
| 42291-094 | Azelastine Hydrochloride | Azelastine |
| 42291-153 | AZELASTINE HYDROCHLORIDE | AZELASTINE HYDROCHLORIDE |
| 47335-779 | Azelastine Hydrochloride | Azelastine Hydrochloride |
| 47335-938 | Azelastine Hydrochloride | Azelastine Hydrochloride |
| 50090-2330 | Azelastine Hydrochloride | azelastine hydrochloride |
| 50090-2538 | Azelastine Hydrochloride | Azelastine Hydrochloride |
| 50090-3833 | Azelastine Hydrochloride | Azelastine |
| 50383-738 | Azelastine Hydrochloride | Azelastine Hydrochloride |
| 50383-942 | Azelastine Hydrochloride | Azelastine Hydrochloride |
| 51525-0234 | AZELASTINE HYDROCHLORIDE | azelastine hydrochloride |
| 51525-0294 | Azelastine Hydrochloride | Azelastine Hydrochloride |
| 51991-814 | AZELASTINE HYDROCHLORIDE | AZELASTINE HYDROCHLORIDE |
| 53002-1279 | Azelastine Hydrochloride | azelastine hydrochloride |
| 53002-2279 | Azelastine Hydrochloride | Azelastine Hydrochloride |
| 59651-214 | AZELASTINE HYDROCHLORIDE | AZELASTINE HYDROCHLORIDE |
| 68071-4359 | Azelastine Hydrochloride | Azelastine Hydrochloride |
| 68382-415 | AZELASTINE HYDROCHLORIDE | AZELASTINE HYDROCHLORIDE |
| 70771-1313 | AZELASTINE HYDROCHLORIDE | AZELASTINE HYDROCHLORIDE |
| 76519-1222 | AZELASTINE HYDROCHLORIDE | AZELASTINE HYDROCHLORIDE |
| 60505-0578 | AZELASTINE HYDROCHLORIDE | AZELASTINE HYDROCHLORIDE |
| 60505-0848 | Azelastine Hydrochloride | Azelastine Hydrochloride |
| 60505-0833 | Azelastine Hydrochloride | Azelastine Hydrochloride |
| 61314-308 | Azelastine Hydrochloride | Azelastine Hydrochloride |
| 65162-706 | Azelastine Hydrochloride | Azelastine Hydrochloride |
| 65162-676 | Azelastine Hydrochloride | Azelastine Hydrochloride |
| 70069-091 | Azelastine Hydrochloride | Azelastine Hydrochloride |
| 68083-287 | Azelastine Hydrochloride | Azelastine Hydrochloride |
| 71205-449 | Azelastine Hydrochloride | Azelastine Hydrochloride |
| 0037-0241 | Astelin | azelastine hydrochloride |
| 0037-0242 | Astepro | Azelastine Hydrochloride |
| 0037-0243 | Astepro | Azelastine Hydrochloride |