Details for New Drug Application (NDA): 214201
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NDA 214201 describes DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM, which is a drug marketed by Anda Repository and Annora Pharma and is included in two NDAs. It is available from two suppliers. Additional details are available on the DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM profile page.
The generic ingredient in DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM is diatrizoate meglumine; diatrizoate sodium. There are eleven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the diatrizoate meglumine; diatrizoate sodium profile page.
The generic ingredient in DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM is diatrizoate meglumine; diatrizoate sodium. There are eleven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the diatrizoate meglumine; diatrizoate sodium profile page.
Summary for 214201
| Tradename: | DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM |
| Applicant: | Anda Repository |
| Ingredient: | diatrizoate meglumine; diatrizoate sodium |
| Patents: | 0 |
Pharmacology for NDA: 214201
| Mechanism of Action | X-Ray Contrast Activity |
Suppliers and Packaging for NDA: 214201
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM | diatrizoate meglumine; diatrizoate sodium | SOLUTION;ORAL, RECTAL | 214201 | ANDA | Guardian Drug Company | 53041-688 | 53041-688-03 | 120 mL in 1 BOTTLE, PLASTIC (53041-688-03) |
| DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM | diatrizoate meglumine; diatrizoate sodium | SOLUTION;ORAL, RECTAL | 214201 | ANDA | Guardian Drug Company | 53041-690 | 53041-690-03 | 120 mL in 1 BOTTLE, GLASS (53041-690-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL, RECTAL | Strength | 66%;10% | ||||
| Approval Date: | Jun 27, 2022 | TE: | AA | RLD: | No | ||||
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