Details for New Drug Application (NDA): 215184
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NDA 215184 describes METOLAZONE, which is a drug marketed by Alembic, Ani Pharms, Bayshore Pharms Llc, Chemistry Hlth, Innogenix, Micro Labs, Mylan, Ne Rx Pharma, Renata, Roxane, Rubicon, Sandoz, and Watson Labs, and is included in fourteen NDAs. It is available from eighteen suppliers. Additional details are available on the METOLAZONE profile page.
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.
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 215184
| Tradename: | METOLAZONE |
| Applicant: | Rubicon |
| Ingredient: | metolazone |
| Patents: | 0 |
Pharmacology for NDA: 215184
| Physiological Effect | Increased Diuresis |
Medical Subject Heading (MeSH) Categories for 215184
Suppliers and Packaging for NDA: 215184
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METOLAZONE | metolazone | TABLET;ORAL | 215184 | ANDA | A-S Medication Solutions | 50090-6972 | 50090-6972-0 | 30 TABLET in 1 BOTTLE (50090-6972-0) |
| METOLAZONE | metolazone | TABLET;ORAL | 215184 | ANDA | Advagen Pharma Limited | 72888-052 | 72888-052-01 | 100 TABLET in 1 BOTTLE (72888-052-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Aug 20, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Aug 20, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Aug 20, 2021 | TE: | AB | RLD: | No | ||||
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