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Details for New Drug Application (NDA): 022203
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. Seventeen 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. Seventeen 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 | 0037-0242 | 0037-0242-30 | 1 BOTTLE, SPRAY in 1 BOX (0037-0242-30) > 200 SPRAY, METERED in 1 BOTTLE, SPRAY |
| 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 |
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 | |||||
| Regulatory Exclusivity Expiration: | Feb 20, 2018 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Patent: | ➤ Sign Up | Patent Expiration: | Jun 4, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ➤ Sign Up | Patent Expiration: | Nov 22, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ALLERGIC RHINITIS, INCLUDING SEASONAL AND PERENNIAL ALLERGIC RHINITIS | ||||||||
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