Details for New Drug Application (NDA): 021545
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NDA 021545 describes PATADAY ONCE DAILY RELIEF, which is a drug marketed by Alcon Labs Inc and is included in two NDAs. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the PATADAY ONCE DAILY RELIEF profile page.
The generic ingredient in PATADAY ONCE DAILY RELIEF is olopatadine hydrochloride. There are seventeen drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the olopatadine hydrochloride profile page.
The generic ingredient in PATADAY ONCE DAILY RELIEF is olopatadine hydrochloride. There are seventeen drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the olopatadine hydrochloride profile page.
Summary for 021545
| Tradename: | PATADAY ONCE DAILY RELIEF |
| Applicant: | Alcon Labs Inc |
| Ingredient: | olopatadine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 021545
| Mechanism of Action | Histamine H1 Receptor Antagonists |
| Physiological Effect | Decreased Histamine Release |
Medical Subject Heading (MeSH) Categories for 021545
Suppliers and Packaging for NDA: 021545
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PATADAY ONCE DAILY RELIEF | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 021545 | NDA | Alcon Laboratories, Inc. | 0065-8150 | 0065-8150-01 | 1 BOTTLE, PLASTIC in 1 CARTON (0065-8150-01) / 2.5 mL in 1 BOTTLE, PLASTIC |
| PATADAY ONCE DAILY RELIEF | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 021545 | NDA | Alcon Laboratories, Inc. | 0065-8150 | 0065-8150-03 | 2 BOTTLE, PLASTIC in 1 CARTON (0065-8150-03) / 2.5 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 0.2% BASE | ||||
| Approval Date: | Dec 22, 2004 | TE: | RLD: | Yes | |||||
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