Details for New Drug Application (NDA): 202511
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NDA 202511 describes SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE, which is a drug marketed by Alkem Labs Ltd, Bionpharma, Novel Labs Inc, Pai Holdings, Strides Pharma, and Taro, and is included in six NDAs. It is available from five suppliers. Additional details are available on the SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE profile page.
The generic ingredient in SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE is magnesium sulfate; potassium sulfate; sodium sulfate. There are one hundred and forty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the magnesium sulfate; potassium sulfate; sodium sulfate profile page.
The generic ingredient in SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE is magnesium sulfate; potassium sulfate; sodium sulfate. There are one hundred and forty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the magnesium sulfate; potassium sulfate; sodium sulfate profile page.
Summary for 202511
| Tradename: | SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE |
| Applicant: | Novel Labs Inc |
| Ingredient: | magnesium sulfate; potassium sulfate; sodium sulfate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 202511
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | magnesium sulfate; potassium sulfate; sodium sulfate | SOLUTION;ORAL | 202511 | ANDA | Novel Laboratories, Inc. | 40032-700 | 40032-700-83 | 2 BOTTLE in 1 CARTON (40032-700-83) / 177 mL in 1 BOTTLE |
| SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | magnesium sulfate; potassium sulfate; sodium sulfate | SOLUTION;ORAL | 202511 | ANDA | Lupin Pharmaceuticals, Inc. | 43386-700 | 43386-700-02 | 1 BOTTLE in 1 CONTAINER (43386-700-02) / 177 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | ||||
| Approval Date: | Feb 23, 2017 | TE: | AA | RLD: | No | ||||
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