Details for New Drug Application (NDA): 214331
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NDA 214331 describes ACETAMINOPHEN, which is a drug marketed by Rising, Aspiro, B Braun Medical, Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma, Inforlife, Mylan, Sandoz, Wockhardt Bio Ag, Zydus Pharms, Able, Acino Prods, Perrigo New York, Taro, Aurobindo Pharma, Granules, Heritage Pharma, Marksans Pharma, Ohm Labs, Perrigo, Sun Pharm Inds Ltd, Teva, Actavis Mid Atlantic, Chartwell, Chartwell Molecular, Dava Pharms Inc, Genus Lifesciences, Pai Holdings, Pharmobedient, Strides Pharma, Am Therap, Amneal Pharms Ny, Ani Pharms, Aurolife Pharma Llc, Duramed Pharms Barr, Elite Labs Inc, Everylife, Fosun Pharma, Halsey, Hibrow Hlthcare, Kv Pharm, Lederle, Mikart, Mutual Pharm, Puracap Pharm, Purepac Pharm, Rhodes Pharms, Roxane, Specgx Llc, Strides Pharma Intl, Superpharm, Usl Pharma, Valeant Pharm Intl, Vitarine, Warner Chilcott, Watson Labs, Watson Labs Florida, Whiteworth Town Plsn, Cent Pharms, Aurobindo Pharma Ltd, Bionpharma, Dr Reddys, Glenmark Pharms Ltd, L Perrigo Co, Gavis Pharms, Wraser Pharms Llc, Boca Pharma Llc, and West-ward Pharm Corp, and is included in one hundred and forty-two NDAs. It is available from one hundred suppliers. There is one patent protecting this drug. Additional details are available on the ACETAMINOPHEN profile page.
The generic ingredient in ACETAMINOPHEN is acetaminophen; caffeine; dihydrocodeine bitartrate. There are sixty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the acetaminophen; caffeine; dihydrocodeine bitartrate profile page.
The generic ingredient in ACETAMINOPHEN is acetaminophen; caffeine; dihydrocodeine bitartrate. There are sixty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the acetaminophen; caffeine; dihydrocodeine bitartrate profile page.
Summary for 214331
| Tradename: | ACETAMINOPHEN |
| Applicant: | Baxter Hlthcare Corp |
| Ingredient: | acetaminophen |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 214331
Suppliers and Packaging for NDA: 214331
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ACETAMINOPHEN | acetaminophen | SOLUTION;INTRAVENOUS | 214331 | ANDA | Baxter Healthcare Corporation | 36000-306 | 36000-306-60 | 40 BAG in 1 CARTON (36000-306-60) / 100 mL in 1 BAG |
| ACETAMINOPHEN | acetaminophen | SOLUTION;INTRAVENOUS | 214331 | ANDA | Baxter Healthcare Corporation | 36000-372 | 36000-372-40 | 40 BAG in 1 CARTON (36000-372-40) / 65 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 1GM/100ML (10MG/ML) | ||||
| Approval Date: | Sep 17, 2021 | TE: | AP1 | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 650MG/65ML (10MG/ML) | ||||
| Approval Date: | May 21, 2025 | TE: | RLD: | No | |||||
| Regulatory Exclusivity Expiration: | Jan 7, 2026 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
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