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Acetic acid, glacial; hydrocortisoneis the generic ingredient in six branded drugs marketed by Actavis Mid Atlantic, Kv Pharm, Bausch And Lomb, Taro Pharm Inds Ltd, Vintage, Wockhardt, Warner Chilcott, Hi Tech Pharma, and Bayer Pharms, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.
There are thirty-six drug master file entries for acetic acid, glacial; hydrocortisone. Two suppliers are listed for this compound.
Pharmacology for acetic acid, glacial; hydrocortisone
|Drug Class||Corticosteroid |
|Mechanism of Action||Corticosteroid Hormone Receptor Agonists |
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|Kv Pharm||ACETIC ACID W/ HYDROCORTISONE||acetic acid, glacial; hydrocortisone||SOLUTION/DROPS;OTIC||085492-001||Approved Prior to Jan 1, 1982||DISCN||No||No||Start Trial||Start Trial||Start Trial|
|Bayer Pharms||NEO-CORT-DOME||acetic acid, glacial; hydrocortisone; neomycin sulfate||SUSPENSION/DROPS;OTIC||050238-001||Approved Prior to Jan 1, 1982||DISCN||No||No||Start Trial||Start Trial||Start Trial|
|Actavis Mid Atlantic||ACETASOL HC||acetic acid, glacial; hydrocortisone||SOLUTION/DROPS;OTIC||087143-001||Jan 13, 1982||DISCN||No||No||Start Trial||Start Trial||Start Trial|
|Warner Chilcott||ORLEX HC||acetic acid, glacial; hydrocortisone||SOLUTION/DROPS;OTIC||086844-001||Approved Prior to Jan 1, 1982||DISCN||No||No||Start Trial||Start Trial||Start Trial|
|Wockhardt||HYDROCORTISONE AND ACETIC ACID||acetic acid, glacial; hydrocortisone||SOLUTION/DROPS;OTIC||040168-001||Aug 30, 1996||DISCN||No||No||Start Trial||Start Trial||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
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