Details for New Drug Application (NDA): 076514
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NDA 076514 describes MIDODRINE HYDROCHLORIDE, which is a drug marketed by Alembic, Apotex, Aurobindo Pharma Ltd, Chartwell Rx, Endo Operations, Impax Pharms, Mankind Pharma, Mylan Pharms Inc, Novugen, Rubicon, Thinq Pharm-cro Pvt, Xiromed, and Zydus Lifesciences, and is included in thirteen NDAs. It is available from twenty-seven suppliers. Additional details are available on the MIDODRINE HYDROCHLORIDE profile page.
The generic ingredient in MIDODRINE HYDROCHLORIDE is midodrine hydrochloride. There are thirteen drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the midodrine hydrochloride profile page.
The generic ingredient in MIDODRINE HYDROCHLORIDE is midodrine hydrochloride. There are thirteen drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the midodrine hydrochloride profile page.
Summary for 076514
| Tradename: | MIDODRINE HYDROCHLORIDE |
| Applicant: | Chartwell Rx |
| Ingredient: | midodrine hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 076514
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Sep 11, 2003 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Sep 11, 2003 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Jul 2, 2004 | TE: | RLD: | No | |||||
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