Details for New Drug Application (NDA): 204934
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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 204934
Tradename: | NIACIN |
Applicant: | Macleods Pharms Ltd |
Ingredient: | niacin |
Patents: | 0 |
Suppliers and Packaging for NDA: 204934
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NIACIN | niacin | TABLET, EXTENDED RELEASE;ORAL | 204934 | ANDA | Macleods Pharmaceuticals Limited | 33342-187 | 33342-187-10 | 90 TABLET in 1 BOTTLE (33342-187-10) |
NIACIN | niacin | TABLET, EXTENDED RELEASE;ORAL | 204934 | ANDA | Macleods Pharmaceuticals Limited | 33342-187 | 33342-187-11 | 100 TABLET in 1 BOTTLE (33342-187-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 500MG | ||||
Approval Date: | Mar 3, 2022 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 1GM | ||||
Approval Date: | Mar 3, 2022 | TE: | AB | RLD: | No |
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