Details for New Drug Application (NDA): 214028
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NDA 214028 describes VUITY, which is a drug marketed by Abbvie and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the VUITY profile page.
The generic ingredient in VUITY is pilocarpine hydrochloride. There are twelve drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the pilocarpine hydrochloride profile page.
The generic ingredient in VUITY is pilocarpine hydrochloride. There are twelve drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the pilocarpine hydrochloride profile page.
Summary for 214028
| Tradename: | VUITY |
| Applicant: | Abbvie |
| Ingredient: | pilocarpine hydrochloride |
| Patents: | 2 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 214028
| Mechanism of Action | Cholinergic Agonists Cholinergic Muscarinic Agonists |
Suppliers and Packaging for NDA: 214028
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VUITY | pilocarpine hydrochloride | SOLUTION;OPHTHALMIC | 214028 | NDA | AbbVie Inc. | 0074-7098 | 0074-7098-01 | 1 BOTTLE in 1 BOX (0074-7098-01) / 2.5 mL in 1 BOTTLE (0074-7098-02) |
| VUITY | pilocarpine hydrochloride | SOLUTION;OPHTHALMIC | 214028 | NDA | AbbVie Inc. | 0074-7098 | 0074-7098-03 | 3 BOTTLE in 1 BOX (0074-7098-03) / 2.5 mL in 1 BOTTLE (0074-7098-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;OPHTHALMIC | Strength | 1.25% | ||||
| Approval Date: | Oct 28, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 28, 2026 | ||||||||
| Regulatory Exclusivity Use: | ADDITION OF SECOND DOSE FOR TREATMENT OF PRESBYOPIA IN ADULTS | ||||||||
| Regulatory Exclusivity Expiration: | Oct 28, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Apr 24, 2039 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF PRESBYOPIA IN ADULTS BY ADMINISTRATION OF PILOCARPINE HCI FORMULATION ONCE DAILY | ||||||||
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