Details for New Drug Application (NDA): 022402
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NDA 022402 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 022402
| Tradename: | CODEINE SULFATE |
| Applicant: | Hikma |
| Ingredient: | codeine sulfate |
| Patents: | 0 |
Pharmacology for NDA: 022402
| Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 022402
Suppliers and Packaging for NDA: 022402
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CODEINE SULFATE | codeine sulfate | TABLET;ORAL | 022402 | NDA | Hikma Pharmaceuticals USA Inc. | 0054-0243 | 0054-0243-24 | 10 BLISTER PACK in 1 BOX (0054-0243-24) / 10 TABLET in 1 BLISTER PACK |
| CODEINE SULFATE | codeine sulfate | TABLET;ORAL | 022402 | NDA | Hikma Pharmaceuticals USA Inc. | 0054-0244 | 0054-0244-24 | 10 BLISTER PACK in 1 BOX (0054-0244-24) / 10 TABLET in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 15MG | ||||
| Approval Date: | Jul 16, 2009 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
| Approval Date: | Jul 16, 2009 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 60MG | ||||
| Approval Date: | Jul 16, 2009 | TE: | AB | RLD: | Yes | ||||
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