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Details for New Drug Application (NDA): 022203
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NDA 022203 describes ASTEPRO, which is a drug marketed by Mylan Speciality Lp and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ASTEPRO profile page.
The generic ingredient in ASTEPRO is azelastine hydrochloride. There are twelve drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride profile page.
The generic ingredient in ASTEPRO is azelastine hydrochloride. There are twelve drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride profile page.
Summary for 022203
| Tradename: | ASTEPRO |
| Applicant: | Mylan Speciality Lp |
| Ingredient: | azelastine hydrochloride |
| Patents: | 3 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 022203
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 022203
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ASTEPRO | azelastine hydrochloride | SPRAY, METERED;NASAL | 022203 | NDA | Meda Pharmaceuticals | 0037-0243 | 0037-0243-04 | 1 BOTTLE, SPRAY in 1 BOX (0037-0243-04) > 22 SPRAY, METERED in 1 BOTTLE, SPRAY |
| ASTEPRO | azelastine hydrochloride | SPRAY, METERED;NASAL | 022203 | NDA | Meda Pharmaceuticals | 0037-0243 | 0037-0243-30 | 1 BOTTLE, SPRAY in 1 BOX (0037-0243-30) > 200 SPRAY, METERED in 1 BOTTLE, SPRAY |
Paragraph IV (Patent) Challenges for 022203
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ASTEPRO | SPRAY, METERED;NASAL | azelastine hydrochloride | 022203 | 2011-12-15 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SPRAY, METERED;NASAL | Strength | EQ 0.125MG BASE/SPRAY | ||||
| Approval Date: | Oct 15, 2008 | TE: | RLD: | No | |||||
| Patent: | Start Trial | Patent Expiration: | Jun 4, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | Start Trial | Patent Expiration: | Nov 22, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ALLERGIC RHINITIS, INCLUDING SEASONAL AND PERENNIAL ALLERGIC RHINITIS | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY, METERED;NASAL | Strength | EQ 0.1876MG BASE/SPRAY | ||||
| Approval Date: | Aug 31, 2009 | TE: | AB | RLD: | Yes | ||||
| Patent: | Start Trial | Patent Expiration: | Jun 4, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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