Details for New Drug Application (NDA): 216216
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NDA 216216 describes METOLAZONE, which is a drug marketed by Alembic, Ani Pharms, Bayshore Pharms Llc, Chemistry Hlth, Innogenix, Mylan, Ne Rx Pharma, Renata, Roxane, Rubicon, Sandoz, and Watson Labs, and is included in thirteen 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 216216
| Tradename: | METOLAZONE |
| Applicant: | Ne Rx Pharma |
| Ingredient: | metolazone |
| Patents: | 0 |
Pharmacology for NDA: 216216
| Physiological Effect | Increased Diuresis |
Medical Subject Heading (MeSH) Categories for 216216
Suppliers and Packaging for NDA: 216216
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METOLAZONE | metolazone | TABLET;ORAL | 216216 | ANDA | Marlex Pharmaceuticals, Inc. | 10135-765 | 10135-765-01 | 100 TABLET in 1 BOTTLE (10135-765-01) |
| METOLAZONE | metolazone | TABLET;ORAL | 216216 | ANDA | Marlex Pharmaceuticals, Inc. | 10135-765 | 10135-765-10 | 1000 TABLET in 1 BOTTLE (10135-765-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Oct 25, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Oct 25, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Oct 25, 2022 | TE: | AB | RLD: | No | ||||
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