FDA Approval for SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE issued to LANNETT CO INC
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Biotechnology: Pharmaceutical Preparations
Health Care
Abbreviated New Drug Application (ANDA): 209941
Company: LANNETT CO INC
Company: LANNETT CO INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | SOLUTION;ORAL | Prescription | AA | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/15/2024 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209941Orig1s000TA_ltr.pdf |
SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE
SOLUTION;ORAL; 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | SOLUTION;ORAL | Prescription | No | AA | 213924 | ALKEM LABS LTD |
| SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | SOLUTION;ORAL | Prescription | No | AA | 204135 | BIONPHARMA |
| SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | SOLUTION;ORAL | Prescription | No | AA | 209941 | LANNETT CO INC |
| SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | SOLUTION;ORAL | Prescription | No | AA | 202511 | NOVEL LABS INC |
| SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | SOLUTION;ORAL | Prescription | No | AA | 215469 | STRIDES PHARMA |
| SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | SOLUTION;ORAL | Prescription | No | AA | 206431 | TARO |
| SUPREP BOWEL PREP KIT | MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | SOLUTION;ORAL | Prescription | Yes | AA | 022372 | BRAINTREE LABS |