NICOTINE POLACRILEX
PERRIGO R AND D · NICOTINE POLACRILEX
Open FDA's page for this record- Application number
- ANDA077007
- Sponsor name
- PERRIGO R AND D
- Submissions
- Submission type
- SUPPL
- Submission number
- 28
- Submission status
- AP
- Submission status date
- 20150403
- Review priority
- STANDARD
- Submission class code
- LABELING
- Submission class code description
- Labeling
- Submission type
- SUPPL
- Submission number
- 34
- Submission status
- AP
- Submission status date
- 20160619
- Review priority
- STANDARD
- Submission class code
- LABELING
- Submission class code description
- Labeling
- Submission type
- ORIG
- Submission number
- 1
- Submission status
- AP
- Submission status date
- 20060131
- Application docs
- ID
- 31185
- Url
- http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077007ltr.pdf
- Date
- 20060202
- Type
- Letter
- Submission type
- SUPPL
- Submission number
- 24
- Submission status
- AP
- Submission status date
- 20141022
- Review priority
- UNKNOWN
- Submission class code
- MANUF (CMC)
- Submission class code description
- Manufacturing (CMC)
- Submission type
- SUPPL
- Submission number
- 10
- Submission status
- AP
- Submission status date
- 20080414
- Submission class code
- LABELING
- Submission class code description
- Labeling
- Submission type
- SUPPL
- Submission number
- 55
- Submission status
- AP
- Submission status date
- 20250401
- Review priority
- UNKNOWN
- Submission class code
- MANUF (CMC)
- Submission class code description
- Manufacturing (CMC)
- Submission type
- SUPPL
- Submission number
- 51
- Submission status
- AP
- Submission status date
- 20240712
- Review priority
- UNKNOWN
- Submission class code
- MANUF (CMC)
- Submission class code description
- Manufacturing (CMC)
- Submission type
- SUPPL
- Submission number
- 23
- Submission status
- AP
- Submission status date
- 20141103
- Review priority
- STANDARD
- Submission class code
- LABELING
- Submission class code description
- Labeling
- Products
- Product number
- 001
- Reference drug
- No
- Brand name
- NICOTINE POLACRILEX
- Reference standard
- No
- Dosage form
- TROCHE/LOZENGE
- Route
- ORAL
- Marketing status
- Over-the-counter
- Active ingredients
- Name
- NICOTINE POLACRILEX
- Strength
- EQ 2MG BASE
- Product number
- 002
- Reference drug
- No
- Brand name
- NICOTINE POLACRILEX
- Reference standard
- No
- Dosage form
- TROCHE/LOZENGE
- Route
- ORAL
- Marketing status
- Over-the-counter
- Active ingredients
- Name
- NICOTINE POLACRILEX
- Strength
- EQ 4MG BASE
- Harmonized identifiers (openFDA)
- Application number
- ANDA077007
- Brand name
- NICOTINE, FOSTER AND THRIVE NICOTINE, BASIC CARE NICOTINE, NICOTINE POLACRILEX, EQUATE NICOTINE, QUITINE NICOTINE, KIRKLAND SIGNATURE QUIT 4, CAREONE NICOTINE, CARE ONE NICOTINE, NICOTINE LOZENGE, GOOD SENSE NICOTINE, BERKLEY AND JENSEN NICOTINE POLACRILEX, EUQATE NICOTINE, UP AND UP NICOTINE, MEMBERS MARK NICOTINE, NICORETTE, UP AND UP MINT NICOTINE, TOPCARE NICOTINE, SIGNATURE CARE NICOTINE, NICOTINE COATED, BERKLEY AND JENSEN NICOTINE, STOP SMOKING AID, EXCHANGE SELECT NICOTINE, KIRKLAND SIGNATURE QUIT 2
- Generic name
- NICOTINE POLACRILEX, NICOTINE
- Manufacturer name
- Walgreen Company, Strategic Sourcing Services LLC, Meijer, Inc., Amazon.com Services LLC, Padagis Israel Pharmaceuticals Ltd, WALMART INC., CVS Pharmacy, QUITINE LLC, Meijer Distribution Inc, Costco Wholesale Company, American Sales Company, Wal-Mart Stores Inc, Sixarp, LLC, Rite Aid Corporation, H E B, L. Perrigo Company, HyVee Inc, Kroger Company, CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED, BJWC, Target Corporation, Sam's West Inc, Haleon US Holdings LLC, Safeway, Topco Associates LLC, Publix Super Markets Inc, Army & Air Force Exchange Service
- Product NDC
- 0363-2511, 70677-1176, 79481-1123, 72288-873, 72288-509, 45802-873, 79903-353, 59779-873, 0363-4049, 84720-000, 41250-344, 63981-873, 41520-701, 49035-998, 59368-463, 41520-873, 11822-1720, 37808-674, 0113-2502, 69842-587, 79481-1100, 42507-690, 30142-873, 11822-1649, 51316-319, 0113-5023, 72288-492, 68391-873, 72288-869, 51316-787, 79903-101, 0113-0873, 82442-741, 68196-082, 0135-0635, 0135-0636, 82442-344, 0363-0873, 21130-636, 79903-182 +34 more
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Substance name
- NICOTINE
- RxCUI
- 359817, 359818, 968849, 968851
- SPL ID
- fef4f418-2f35-4c51-8c7c-608284130b5d, 435d770f-4f36-4da5-83b6-2c965318a930, 8946235f-be6c-4745-a038-eb3dd0f4a5df, 349ea84d-47ad-4c23-9930-e71508486bb3, 9582d831-2347-465c-af54-99ce27f4effb, 574b2fe4-a95b-400d-a107-4658e84f7d87, bc8f40d6-58c8-49d3-a0ba-d239019bbb0a, 2a34c905-d0bd-4619-909a-cd2fd92c5efc, 8cd1928b-b6cc-425f-91ee-dde130ad3ebc, 7f1065cd-fed9-473c-84d3-6e13cdbd683c, 49f6155b-23e3-430a-a898-ccb0d4ebbeb9, e2cd5ccc-3e88-49e7-9fd7-29ac2b9b8089, e1e056f5-68b5-43fc-b469-f6e130a9aec2, 0cbc7c2c-06e2-4e3e-9d48-bcfb0fb602d3, 5a94092b-f80f-c656-e063-6294a90ab15a, cb9f3baa-5250-4a13-ae9e-f8dc8a44c771, db4c8a29-4afc-43a6-8e43-769e8120eea6, f186f7fc-7b7a-4029-a404-99e5f2e1f557, 2ad48d3a-64a0-4428-86ad-0899b5952e37, c1c88c02-a362-4606-9118-3195bbb98eff, 7ecd9a6a-1237-4375-b72c-9f2e30557650, b173622b-e105-466d-8858-f95a2c866271, 57d9ff9a-281c-4de2-a4ba-905f6a8c14d9, 94586c28-b75d-45d3-b774-b1e986d43f2d, 5940839d-b529-4737-a2a7-60e7cd7f168b, 8e5e7acc-edb8-4230-b40a-117266b3f126, 793d93fa-0b0a-4601-b4c1-a71a45978382, 1b1ebcd0-e7ac-4c86-a922-fd02744b427e, 390a739a-9117-48a7-ac15-b77d13da0e9b, 2f80c43a-8b04-42aa-ae89-50266b74f4b3, 012bcc52-fb21-4b53-9bed-aa144d6d9ee3, 812f7fdb-e2b7-43f3-b24e-36a33eec32d6, 3c75711c-056e-4861-a6a0-100797212454, 4f7bd0c2-296a-496f-b6d1-87dd884d8a72, fd080df4-10ba-4b7e-a999-474f51610d2a, 5990e480-2d19-413c-ae74-c9d2910b8ca5, bdd5bb7b-8a44-48ac-acee-c9cb5ef3cb13, 461718e6-2a05-44b5-b6b0-509f2064c3aa, ad49b333-a8d2-4355-b2af-641b38ba8ddf, 384a94be-0b87-4c1a-ba48-1f5f64e47d89 +33 more
- SPL set ID
- 5dd116ea-d031-439c-b06c-2f77230bc446, 7eed43bd-b26c-41cd-b2bc-74d6c15b376c, 8b9f4dfc-9469-449d-9434-656aeccc4fd6, 8cc8de15-5906-4749-99f2-2884c6a1842a, d6566f92-cf41-4032-a66b-3d1cdf661f33, 8d4dfba9-1571-4128-9cdc-47cdce04e3e4, b6379f86-1528-465d-9527-bd2fead0068f, 4bc94e0b-189f-47b0-826c-2ccf6c4a0e3a, af8fadbb-25a7-4ab7-a665-808e4b41978a, fd9ce0e2-b159-4e0d-a76e-7223d36810fb, 7be33f47-03de-458d-81b9-5a8d94052075, cd1c3493-242c-4981-8561-ebbea938628f, 84ed0acf-dcd3-4d4a-8e5c-f75f48993b34, 19fad004-2997-4169-939a-dc525dc9e6cc, 5a94092b-f80e-c656-e063-6294a90ab15a, 1b6be939-cd9d-4ab4-b291-096cf498cf92, c94d46b1-f526-4af0-8f7c-8261b9ed6841, db78d030-7abf-494f-94ca-4a385f519faf, 0ac7f87a-63f4-4d74-ba5b-d1444803b100, a7348e93-bc5d-48d8-b2a4-daf921343d44, aee78555-7851-46a5-b9fa-c98b46354619, 6415ebf4-5b6f-4811-997d-27c76893bc04, 35f45900-af2e-4b74-9772-8beb55236457, 09bc9f57-fed2-42d9-b4f2-2b71b8baa0a9, 0ef9e55d-83e0-4ba5-a905-8cddb0db0019, 5c89061b-1452-4962-9f25-212f2ae8e41e, afc71ce1-ded2-4259-a9e1-faca692b90a1, b586ce1c-77cd-497c-b22c-8c97f54583ba, 8430a12b-4a7b-48a1-aa8f-7e55c5fde3c0, 9ba85e0a-bcb7-4803-8d21-0eb93768cb3a, c1764aad-1da4-4e4e-b6b0-5a3df1edda85, ee345181-4999-4948-9589-7d70d61885ad, 65a612e8-18d3-49fd-844f-4ccd0210acd3, 78126814-286e-485f-a4ce-77587f3d77e3, ffeb8286-860d-49f5-8df3-724afb4aaad8, 740833d6-5406-4609-9d14-bd5c9072fe9a, 77688e56-4293-4f37-9f48-fe09267ff619, 97ad8d6d-813f-4c59-93a1-184c913162ea, 0f625e1a-be08-4460-a588-8b42282ac121, 6b500780-f45c-477c-8371-3b60e3305000 +33 more
- Package NDC
- 0363-2511-40, 0363-2511-27, 70677-1176-1, 79481-1123-0, 79481-1123-2, 79481-1123-1, 72288-873-16, 72288-873-03, 72288-873-14, 72288-509-76, 72288-509-58, 45802-873-03, 45802-873-05, 79903-353-20, 79903-353-40, 79903-353-80, 59779-873-03, 59779-873-04, 59779-873-05, 59779-873-06, 59779-873-09, 59779-873-10, 59779-873-11, 0363-4049-01, 0363-4049-02, 84720-000-58, 84720-000-76, 41250-344-05, 41250-344-11, 41250-344-10, 41250-344-06, 41250-344-03, 63981-873-09, 63981-873-37, 41520-701-05, 49035-998-03, 49035-998-09, 49035-998-10, 49035-998-11, 59368-463-01 +142 more
- Nui
- N0000175706, M0014836
- Pharm class epc
- Cholinergic Nicotinic Agonist [EPC]
- Pharm class cs
- Nicotine [CS]
- UNII
- 6M3C89ZY6R