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Details for New Drug Application (NDA): 012945
NDA 012945 describes DIAMOX, which is a drug marketed by Teva Branded Pharm and Teva Womens and is included in three NDAs. It is available from two suppliers. Additional details are available on the DIAMOX profile page.
The generic ingredient in DIAMOX is acetazolamide sodium. There are ten drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the acetazolamide sodium profile page.
The generic ingredient in DIAMOX is acetazolamide sodium. There are ten drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the acetazolamide sodium profile page.
Summary for 012945
| Tradename: | DIAMOX |
| Applicant: | Teva Branded Pharm |
| Ingredient: | acetazolamide |
| Patents: | 0 |
| Therapeutic Class: | Ophthalmic Agents |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 012945
| Ingredient-type | Sulfonamides |
| Mechanism of Action | Carbonic Anhydrase Inhibitors |
Medical Subject Heading (MeSH) Categories for 012945
Suppliers and Packaging for NDA: 012945
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DIAMOX | acetazolamide | CAPSULE, EXTENDED RELEASE;ORAL | 012945 | NDA AUTHORIZED GENERIC | Teva Pharmaceuticals USA, Inc. | 0555-0513 | N | 0555-0513-02 |
| DIAMOX | acetazolamide | CAPSULE, EXTENDED RELEASE;ORAL | 012945 | NDA | Teva Women's Health, Inc. | 51285-754 | N | 51285-754-02 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 500MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
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