Details for New Drug Application (NDA): 076698
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The generic ingredient in METOLAZONE is metolazone. There are ten drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the metolazone profile page.
Summary for 076698
Tradename: | METOLAZONE |
Applicant: | Mylan |
Ingredient: | metolazone |
Patents: | 0 |
Pharmacology for NDA: 076698
Physiological Effect | Increased Diuresis |
Medical Subject Heading (MeSH) Categories for 076698
Suppliers and Packaging for NDA: 076698
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METOLAZONE | metolazone | TABLET;ORAL | 076698 | ANDA | Mylan Pharmaceuticals Inc. | 0378-6172 | 0378-6172-01 | 100 TABLET in 1 BOTTLE, PLASTIC (0378-6172-01) |
METOLAZONE | metolazone | TABLET;ORAL | 076698 | ANDA | Mylan Pharmaceuticals Inc. | 0378-6173 | 0378-6173-01 | 100 TABLET in 1 BOTTLE, PLASTIC (0378-6173-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
Approval Date: | Dec 23, 2003 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Oct 19, 2004 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Oct 19, 2004 | TE: | AB | RLD: | No |
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