Details for New Drug Application (NDA): 206185
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The generic ingredient in XELPROS is latanoprost. There are twenty drug master file entries for this compound. Thirteen 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 |
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: | DISCN | Dosage: | EMULSION;OPHTHALMIC | Strength | 0.005% | ||||
Approval Date: | Sep 12, 2018 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | 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: | ⤷ Sign Up | Patent Expiration: | Sep 12, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? |
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