Details for New Drug Application (NDA): 203046
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NDA 203046 describes CODEINE SULFATE, which is a drug marketed by Hikma and Lannett Co Inc and is included in three NDAs. It is available from two suppliers. Additional details are available on the CODEINE SULFATE profile page.
The generic ingredient in CODEINE SULFATE is codeine sulfate. There are nineteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the codeine sulfate profile page.
The generic ingredient in CODEINE SULFATE is codeine sulfate. There are nineteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the codeine sulfate profile page.
Summary for 203046
| Tradename: | CODEINE SULFATE |
| Applicant: | Lannett Co Inc |
| Ingredient: | codeine sulfate |
| Patents: | 0 |
Pharmacology for NDA: 203046
| Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 203046
Suppliers and Packaging for NDA: 203046
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CODEINE SULFATE | codeine sulfate | TABLET;ORAL | 203046 | ANDA | Lannett Company, Inc. | 0527-1698 | 0527-1698-01 | 100 TABLET in 1 BOTTLE (0527-1698-01) |
| CODEINE SULFATE | codeine sulfate | TABLET;ORAL | 203046 | ANDA | Lannett Company, Inc. | 0527-1698 | 0527-1698-91 | 4 BLISTER PACK in 1 CARTON (0527-1698-91) / 25 TABLET in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 15MG | ||||
| Approval Date: | Jun 13, 2014 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
| Approval Date: | Jun 13, 2014 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 60MG | ||||
| Approval Date: | Jun 13, 2014 | TE: | AB | RLD: | No | ||||
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