Nicotine Polacrilex Gum is a Buccal Gum, Chewing in the Human Otc Drug category. It is labeled and distributed by Fertin Pharma A/s. The primary component is Nicotine.
| Product ID | 63443-5057_f1773a09-cd15-bc3b-e053-2995a90a683b |
| NDC | 63443-5057 |
| Product Type | Human Otc Drug |
| Proprietary Name | Nicotine Polacrilex Gum |
| Generic Name | Nicotine Polacrilex |
| Dosage Form | Gum, Chewing |
| Route of Administration | BUCCAL |
| Marketing Start Date | 2022-12-21 |
| Marketing Category | ANDA / |
| Application Number | ANDA214354 |
| Labeler Name | Fertin Pharma A/S |
| Substance Name | NICOTINE |
| Active Ingredient Strength | 4 mg/1 |
| Pharm Classes | Cholinergic Nicotinic Agonist [EPC], Nicotine [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2024-12-31 |
| Marketing Start Date | 2022-12-21 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 11822-3322 | Nicotine Polacrilex Gum | Nicotine Polacrilex Gum |
| 0113-0704 | basic care nicotine | Nicotine polacrilex |
| 0113-0713 | basic care nicotine | Nicotine Polacrilex |
| 0113-0749 | basic care nicotine | Nicotine Polacrilex |
| 0113-0761 | basic care nicotine | Nicotine Polacrilex |
| 0113-7007 | basic care nicotine | Nicotine Polacrilex |
| 0113-7008 | basic care nicotine | nicotine polacrilex |
| 0113-7029 | basic care nicotine | Nicotine Polacrilex |
| 0113-0029 | Good Sense Nicotine | Nicotine Polacrilex |
| 0113-0053 | Good Sense Nicotine | Nicotine Polacrilex |
| 0113-0170 | Good Sense Nicotine | Nicotine Polacrilex |
| 0113-0206 | good sense nicotine | Nicotine Polacrilex |
| 0113-0344 | Good Sense Nicotine | Nicotine Polacrilex |
| 0113-0422 | Good Sense Nicotine | Nicotine Polacrilex |
| 0113-0456 | Good Sense Nicotine | Nicotine Polacrilex |
| 0113-0532 | Good Sense Nicotine | Nicotine Polacrilex |
| 0113-0734 | Good Sense Nicotine | Nicotine Polacrilex |
| 0113-0854 | Good Sense Nicotine | Nicotine polacrilex |
| 0113-0873 | good sense nicotine | Nicotine Polacrilex |
| 0113-0957 | Good Sense Nicotine | Nicotine Polacrilex |
| 0113-1125 | Good Sense Nicotine | Nicotine Polacrilex |
| 0113-1190 | good sense nicotine | Nicotine Polacrilex |
| 0113-1352 | good sense nicotine | Nicotine Polacrilex |
| 0113-6000 | Tru Relief Nicotine | Nicotine Polacrilex |
| 0113-6001 | Tru Relief Nicotine | Nicotine Polacrilex |