Details for New Drug Application (NDA): 212789
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NDA 212789 describes SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID, which is a drug marketed by Hetero Labs Ltd V and is included in one NDA. Additional details are available on the SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID profile page.
The generic ingredient in SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID is citric acid; magnesium oxide; sodium picosulfate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the citric acid; magnesium oxide; sodium picosulfate profile page.
The generic ingredient in SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID is citric acid; magnesium oxide; sodium picosulfate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the citric acid; magnesium oxide; sodium picosulfate profile page.
Summary for 212789
| Tradename: | SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID |
| Applicant: | Hetero Labs Ltd V |
| Ingredient: | citric acid; magnesium oxide; sodium picosulfate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | 12GM/PACKET;3.5GM/PACKET;10MG/PACKET | ||||
| Approval Date: | Jul 18, 2022 | TE: | RLD: | No | |||||
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