Details for New Drug Application (NDA): 213135
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NDA 213135 describes SUTAB, which is a drug marketed by Braintree Labs and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the SUTAB profile page.
The generic ingredient in SUTAB is magnesium sulfate; potassium chloride; sodium sulfate. There are one hundred and forty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the magnesium sulfate; potassium chloride; sodium sulfate profile page.
The generic ingredient in SUTAB is magnesium sulfate; potassium chloride; sodium sulfate. There are one hundred and forty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the magnesium sulfate; potassium chloride; sodium sulfate profile page.
Summary for 213135
| Tradename: | SUTAB |
| Applicant: | Braintree Labs |
| Ingredient: | magnesium sulfate; potassium chloride; sodium sulfate |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 213135
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 213135
Suppliers and Packaging for NDA: 213135
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SUTAB | magnesium sulfate; potassium chloride; sodium sulfate | TABLET;ORAL | 213135 | NDA | Braintree Laboratories, Inc. | 52268-201 | 52268-201-01 | 2 BOTTLE, PLASTIC in 1 KIT (52268-201-01) / 12 TABLET in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.225GM;0.188GM;1.479GM | ||||
| Approval Date: | Nov 10, 2020 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Aug 4, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Aug 4, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | GASTROINTESTINAL TABLETS INDICATED FOR CLEANSING THE COLON IN PREPARATION FOR COLONOSCOPY | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Aug 4, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | GASTROINTESTINAL TABLETS INDICATED FOR CLEANSING THE COLON IN PREPARATION FOR COLONOSCOPY | ||||||||
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