Generated: December 17, 2017
DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 021463
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, which is a drug marketed by Endo Pharms and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the FORTESTA profile page.
The generic ingredient in FORTESTA is testosterone. There are sixty-two drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the testosterone profile page.
Pharmacology for NDA: 021463
Medical Subject Heading (MeSH) Categories for 021463
Suppliers and Packaging for NDA: 021463
||National Drug Code
||NDA AUTHORIZED GENERIC
||1 CANISTER in 1 CARTON (0603-7831-88) > 60 g in 1 CANISTER
||Endo Pharmaceuticals, Inc.
||3 CANISTER in 1 CARTON (63481-183-18) > 60 g in 1 CANISTER
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Summary for product number 001
|Active Rx/OTC/Discontinued:||RX||Dosage:||GEL, METERED;TRANSDERMAL||Strength||10MG/0.5GM ACTUATION|
|Approval Date:||Dec 29, 2010||TE:||AB||RLD:||Yes|
|Patent:||► Subscribe||Patent Expiration:||Nov 9, 2018||Product Flag?||Substance Flag?||Delist Request?|
|Patented Use:||TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE|
|Patent:||► Subscribe||Patent Expiration:||Nov 9, 2018||Product Flag?||Y||Substance Flag?||Delist Request?|
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