Details for New Drug Application (NDA): 212903
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NDA 212903 describes SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE, which is a drug marketed by Alkem Labs Ltd, Annora Pharma, Bionpharma, Novel Labs Inc, Pai Holdings, Strides Pharma Intl, and Taro, and is included in seven NDAs. It is available from eight 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. Ten 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. Ten suppliers are listed for this compound. Additional details are available on the magnesium sulfate; potassium sulfate; sodium sulfate profile page.
Summary for 212903
| Tradename: | SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE |
| Applicant: | Annora Pharma |
| Ingredient: | magnesium sulfate; potassium sulfate; sodium sulfate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 212903
| 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 | 212903 | ANDA | Camber Pharmaceuticals, Inc. | 31722-098 | 31722-098-31 | 2 BOTTLE, PLASTIC in 1 CARTON (31722-098-31) / 177 mL in 1 BOTTLE, PLASTIC (31722-098-17) |
| SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | magnesium sulfate; potassium sulfate; sodium sulfate | SOLUTION;ORAL | 212903 | ANDA | NorthStar RxLLC | 72603-278 | 72603-278-02 | 2 BOTTLE, PLASTIC in 1 CARTON (72603-278-02) / 177 mL in 1 BOTTLE, PLASTIC (72603-278-01) |
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: | Oct 18, 2024 | TE: | AA | RLD: | No | ||||
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