Details for New Drug Application (NDA): 215352
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NDA 215352 describes MYDCOMBI, which is a drug marketed by Eyenovia and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the MYDCOMBI profile page.
The generic ingredient in MYDCOMBI is phenylephrine hydrochloride; tropicamide. There are twenty-one drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the phenylephrine hydrochloride; tropicamide profile page.
The generic ingredient in MYDCOMBI is phenylephrine hydrochloride; tropicamide. There are twenty-one drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the phenylephrine hydrochloride; tropicamide profile page.
Summary for 215352
| Tradename: | MYDCOMBI |
| Applicant: | Eyenovia |
| Ingredient: | phenylephrine hydrochloride; tropicamide |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215352
Generic Entry Date for 215352*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT Dosage:
SPRAY, METERED;OPHTHALMIC |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 215352
| Mechanism of Action | Adrenergic alpha1-Agonists Cholinergic Antagonists |
Suppliers and Packaging for NDA: 215352
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MYDCOMBI | phenylephrine hydrochloride; tropicamide | SPRAY, METERED;OPHTHALMIC | 215352 | NDA | Eyenovia, Inc. | 81046-0111 | 81046-0111-1 | 1 CARTRIDGE in 1 CARTON (81046-0111-1) / 1.9 mL in 1 CARTRIDGE |
| MYDCOMBI | phenylephrine hydrochloride; tropicamide | SPRAY, METERED;OPHTHALMIC | 215352 | NDA | Eyenovia, Inc. | 81046-0111 | 81046-0111-2 | 1 CARTON in 1 BOX (81046-0111-2) / 1 CARTRIDGE in 1 CARTON / 1.9 mL in 1 CARTRIDGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY, METERED;OPHTHALMIC | Strength | 2.5%;1% | ||||
| Approval Date: | May 5, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 5, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | 10,839,960 | Patent Expiration: | Jul 15, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF ADMINISTERING AN EFFECTIVE DOSE OF TROPICAMIDE AND PHENYLEPHRINE HYDROCHLORIDE TO AN EYE | ||||||||
| Patent: | 11,398,306 | Patent Expiration: | Jul 15, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF ADMINISTERING AN EFFECTIVE DOSE OF TROPICAMIDE AND PHENYLEPHRINE HYDROCHLORIDE TO AN EYE | ||||||||
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