Details for New Drug Application (NDA): 209236
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The generic ingredient in NIACIN is niacin. There are fourteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the niacin profile page.
Summary for 209236
Tradename: | NIACIN |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | niacin |
Patents: | 0 |
Suppliers and Packaging for NDA: 209236
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NIACIN | niacin | TABLET, EXTENDED RELEASE;ORAL | 209236 | ANDA | Aurobindo Pharma Limited | 59651-018 | 59651-018-05 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-018-05) |
NIACIN | niacin | TABLET, EXTENDED RELEASE;ORAL | 209236 | ANDA | Aurobindo Pharma Limited | 59651-018 | 59651-018-18 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-018-18) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 500MG | ||||
Approval Date: | Feb 1, 2018 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 750MG | ||||
Approval Date: | Feb 1, 2018 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 1GM | ||||
Approval Date: | Feb 1, 2018 | TE: | AB | RLD: | No |
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