Application Nr Approved Date Route Status External Links
ANDA065485 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Minocycline Hydrochloride Extended-Release Tablets Are A Tetracycline-Class Drug Indicated To Treat Only Inflammatory Lesions Of Non-Nodular Moderate To Severe Acne Vulgaris In Patients 12 Years Of Age And Older. ( 1 ) 1.1 Indication Minocycline Hydrochloride Extended-Release Tablets Are Indicated To Treat Only Inflammatory Lesions Of Non-Nodular Moderate To Severe Acne Vulgaris In Patients 12 Years Of Age And Older. 1.2 Limitations Of Use Minocycline Hydrochloride Extended-Release Tablets Did Not Demonstrate Any Effect On Non-Inflammatory Acne Lesions. Safety Of Minocycline Hydrochloride Extended-Release Tablets Has Not Been Established Beyond 12 Weeks Of Use. This Formulation Of Minocycline Has Not Been Evaluated In The Treatment Of Infections [ See Clinical Studies ( 14 ) ]. To Reduce The Development Of Drug-Resistant Bacteria As Well As To Maintain The Effectiveness Of Other Antibacterial Drugs, Minocycline Hydrochloride Extended-Release Tablets Should Be Used Only As Indicated [ See Warnings And Precautions ( 5.11 ) ].

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Minocycline Hydrochloride MINOCYCLINE HYDROCHLORIDE ZINC14879992

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