Details for New Drug Application (NDA): 213266
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NDA 213266 describes NICOTINE POLACRILEX, which is a drug marketed by Fertin Pharma, Ivax Sub Teva Pharms, L Perrigo Co, P And L, Perrigo R And D, Aurobindo Pharma, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, Pld Acquisitions, and Ppi-dac, and is included in forty-nine NDAs. It is available from sixty suppliers. Additional details are available on the NICOTINE POLACRILEX profile page.
The generic ingredient in NICOTINE POLACRILEX is nicotine polacrilex. There are thirty drug master file entries for this compound. Sixty-one suppliers are listed for this compound. Additional details are available on the nicotine polacrilex profile page.
The generic ingredient in NICOTINE POLACRILEX is nicotine polacrilex. There are thirty drug master file entries for this compound. Sixty-one suppliers are listed for this compound. Additional details are available on the nicotine polacrilex profile page.
Summary for 213266
| Tradename: | NICOTINE POLACRILEX |
| Applicant: | Aurobindo Pharma |
| Ingredient: | nicotine polacrilex |
| Patents: | 0 |
Suppliers and Packaging for NDA: 213266
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NICOTINE POLACRILEX | nicotine polacrilex | TROCHE/LOZENGE;ORAL | 213266 | ANDA | Aurohealth LLC | 58602-835 | 58602-835-07 | 1 CONTAINER in 1 CARTON (58602-835-07) / 24 LOZENGE in 1 CONTAINER |
| NICOTINE POLACRILEX | nicotine polacrilex | TROCHE/LOZENGE;ORAL | 213266 | ANDA | Aurohealth LLC | 58602-835 | 58602-835-51 | 3 CONTAINER in 1 CARTON (58602-835-51) / 24 LOZENGE in 1 CONTAINER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TROCHE/LOZENGE;ORAL | Strength | EQ 2MG BASE | ||||
| Approval Date: | Aug 3, 2021 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TROCHE/LOZENGE;ORAL | Strength | EQ 4MG BASE | ||||
| Approval Date: | Aug 3, 2021 | TE: | RLD: | No | |||||
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