Details for New Drug Application (NDA): 211610
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NDA 211610 describes ACETAMINOPHEN AND CODEINE PHOSPHATE, which is a drug marketed by Teva, Actavis Mid Atlantic, Chartwell, Chartwell Molecular, Dava Pharms Inc, Genus Lifesciences, Pai Holdings, Strides Pharma, Wockhardt Bio Ag, Able, Am Therap, Amneal Pharms Ny, Aurolife Pharma Llc, Duramed Pharms Barr, Elite Labs Inc, Everylife, Fosun Pharma, Halsey, Kv Pharm, Lederle, Mikart, Mutual Pharm, Nostrum Labs Inc, Puracap Pharm, Purepac Pharm, Rhodes Pharms, Roxane, Sandoz, Specgx Llc, Sun Pharm Inds Ltd, Superpharm, Usl Pharma, Valeant Pharm Intl, Vitarine, Warner Chilcott, Watson Labs, Watson Labs Florida, Wes Pharma Inc, and Whiteworth Town Plsn, and is included in eighty-nine NDAs. It is available from thirty suppliers. Additional details are available on the ACETAMINOPHEN AND CODEINE PHOSPHATE profile page.
The generic ingredient in ACETAMINOPHEN AND CODEINE PHOSPHATE is acetaminophen; codeine phosphate. There are sixty-six drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the acetaminophen; codeine phosphate profile page.
The generic ingredient in ACETAMINOPHEN AND CODEINE PHOSPHATE is acetaminophen; codeine phosphate. There are sixty-six drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the acetaminophen; codeine phosphate profile page.
Summary for 211610
| Tradename: | ACETAMINOPHEN AND CODEINE PHOSPHATE |
| Applicant: | Wes Pharma Inc |
| Ingredient: | acetaminophen; codeine phosphate |
| Patents: | 0 |
Pharmacology for NDA: 211610
| Mechanism of Action | Full Opioid Agonists |
Suppliers and Packaging for NDA: 211610
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen; codeine phosphate | TABLET;ORAL | 211610 | ANDA | A-S Medication Solutions | 50090-5198 | 50090-5198-0 | 15 TABLET in 1 BOTTLE (50090-5198-0) |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen; codeine phosphate | TABLET;ORAL | 211610 | ANDA | A-S Medication Solutions | 50090-5200 | 50090-5200-0 | 10 TABLET in 1 BOTTLE (50090-5200-0) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG;15MG | ||||
| Approval Date: | Jun 27, 2019 | TE: | AA | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG;30MG | ||||
| Approval Date: | Jun 27, 2019 | TE: | AA | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG;60MG | ||||
| Approval Date: | Jun 27, 2019 | TE: | AA | RLD: | No | ||||
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