Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

FDA Approval Activities for this Drug… Midodrine Hydrochloride Tablets, Mylan ANDA 76-577 9/10/03 Midodrine Hydrochloride Tablets, Eon Labs, ANDA 76-514 ProAmatine (midodrine hydrochloride) Tablets, 2.5 mg and 5 mg Shire NDA 19-815/S-005 MIDODRINE HYDROCHLORIDE Tablet; 2.5MG MIDODRINE HCL Eon 076514 MIDODRINE HYDROCHLORIDE Tablet; 5MG MIDODRINE HCL Eon 076577 MIDODRINE HYDROCHLORIDE Tablet; 10MG MIDODRINE HCL Mylan 076577 MIDODRINE HYDROCHLORIDE Tablet; 2.5MG MIDODRINE HCL Mylan 076577 MIDODRINE HYDROCHLORIDE Tablet; 5MG MIDODRINE HCL Mylan 019815 MIDODRINE HYDROCHLORIDE Tablet; 10MG PROAMATINE SHIRE 019815 MIDODRINE HYDROCHLORIDE Tablet; 2.5MG PROAMATINE SHIRE 019815 MIDODRINE HYDROCHLORIDE Tablet; 5MG PROAMATINE SHIRE Midodrine Hydrochloride Tablets, Impax Laboratories Midodrine Hydrochloride Tablets, Eon Labs, Approval ProAmatine (midodrine hydrochloride) Tablets, Shire Laboratories, Labeling Revision   For the latest approval information, locate this drug using this index.