Details for New Drug Application (NDA): 012616
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NDA 012616 describes ALDACTAZIDE, which is a drug marketed by Pfizer and is included in one NDA. It is available from one supplier. Additional details are available on the ALDACTAZIDE profile page.
The generic ingredient in ALDACTAZIDE is hydrochlorothiazide; spironolactone. There are thirty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; spironolactone profile page.
The generic ingredient in ALDACTAZIDE is hydrochlorothiazide; spironolactone. There are thirty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; spironolactone profile page.
Summary for 012616
| Tradename: | ALDACTAZIDE |
| Applicant: | Pfizer |
| Ingredient: | hydrochlorothiazide; spironolactone |
| Patents: | 0 |
Suppliers and Packaging for NDA: 012616
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALDACTAZIDE | hydrochlorothiazide; spironolactone | TABLET;ORAL | 012616 | NDA AUTHORIZED GENERIC | Prasco Laboratories | 66993-188 | 66993-188-02 | 100 TABLET, FILM COATED in 1 BOTTLE (66993-188-02) |
Profile for product number 004
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG;25MG | ||||
| Approval Date: | Dec 30, 1982 | TE: | AB | RLD: | Yes | ||||
Profile for product number 005
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 50MG;50MG | ||||
| Approval Date: | Dec 30, 1982 | TE: | RLD: | Yes | |||||
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