Details for New Drug Application (NDA): 206185
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NDA 206185 describes XELPROS, which is a drug marketed by Sun Pharm 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 XELPROS profile page.
The generic ingredient in XELPROS is latanoprost. There are twenty drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the latanoprost profile page.
The generic ingredient in XELPROS is latanoprost. There are twenty drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the latanoprost profile page.
Summary for 206185
| Tradename: | XELPROS |
| Applicant: | Sun Pharm |
| Ingredient: | latanoprost |
| Patents: | 2 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 206185
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| XELPROS | latanoprost | EMULSION;OPHTHALMIC | 206185 | NDA | Sun Pharmaceutical Industries, Inc. | 47335-317 | 47335-317-90 | 1 BOTTLE, DROPPER in 1 BOX (47335-317-90) / 2.5 mL in 1 BOTTLE, DROPPER |
| XELPROS | latanoprost | EMULSION;OPHTHALMIC | 206185 | NDA | Sun Pharmaceutical Industries, Inc. | 47335-317 | 47335-317-92 | 3 BOTTLE, DROPPER in 1 BOX (47335-317-92) / 2.5 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | EMULSION;OPHTHALMIC | Strength | 0.005% | ||||
| Approval Date: | Sep 12, 2018 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Oct 15, 2028 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | REDUCING ELEVATED INTRAOCULAR PRESSURE IN PATIENTS WITH OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Sep 12, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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