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Generated: November 21, 2018

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Details for New Drug Application (NDA): 201922

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NDA 201922 describes XIMINO, which is a drug marketed by Sun Pharm Inds Ltd and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the XIMINO profile page.

The generic ingredient in XIMINO is minocycline hydrochloride. There are fourteen drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.
Summary for 201922
Tradename:XIMINO
Applicant:Sun Pharm Inds Ltd
Ingredient:minocycline hydrochloride
Patents:7
Formulation / Manufacturing:see details
Pharmacology for NDA: 201922
Ingredient-typeTetracyclines
Medical Subject Heading (MeSH) Categories for 201922
Suppliers and Packaging for NDA: 201922
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XIMINO minocycline hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 201922 NDA Sun Pharmaceutical Industries, Inc 10631-330 10631-330-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10631-330-05)
XIMINO minocycline hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 201922 NDA Sun Pharmaceutical Industries, Inc 10631-330 10631-330-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10631-330-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 45MG BASE
Approval Date:Jul 11, 2012TE:RLD:No
Patent:➤ Try a Free TrialPatent Expiration:Feb 19, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS
Patent:➤ Try a Free TrialPatent Expiration:Apr 2, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS
Patent:➤ Try a Free TrialPatent Expiration:Apr 2, 2027Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 201922

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sun Pharm Inds Ltd XIMINO minocycline hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 201922-001 Jul 11, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Sun Pharm Inds Ltd XIMINO minocycline hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 201922-003 Jul 11, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Sun Pharm Inds Ltd XIMINO minocycline hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 201922-005 Jul 11, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Julphar
Deloitte
Boehringer Ingelheim
Fish and Richardson
Baxter
Healthtrust
Daiichi Sankyo
US Army

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