Details for New Drug Application (NDA): 022556
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NDA 022556 describes KARBINAL ER, which is a drug marketed by Aytu and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug. Additional details are available on the KARBINAL ER profile page.
The generic ingredient in KARBINAL ER is carbinoxamine maleate. There are seven drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the carbinoxamine maleate profile page.
The generic ingredient in KARBINAL ER is carbinoxamine maleate. There are seven drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the carbinoxamine maleate profile page.
Summary for 022556
| Tradename: | KARBINAL ER |
| Applicant: | Aytu |
| Ingredient: | carbinoxamine maleate |
| Patents: | 2 |
Pharmacology for NDA: 022556
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 022556
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KARBINAL ER | carbinoxamine maleate | SUSPENSION, EXTENDED RELEASE;ORAL | 022556 | NDA | Aytu Therapeutics, LLC | 23594-101 | 23594-101-01 | 2 BOTTLE, PLASTIC in 1 CARTON (23594-101-01) / 30 mL in 1 BOTTLE, PLASTIC |
| KARBINAL ER | carbinoxamine maleate | SUSPENSION, EXTENDED RELEASE;ORAL | 022556 | NDA | Aytu Therapeutics, LLC | 23594-101 | 23594-101-05 | 480 mL in 1 BOTTLE, PLASTIC (23594-101-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION, EXTENDED RELEASE;ORAL | Strength | 4MG/5ML | ||||
| Approval Date: | Mar 28, 2013 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Mar 29, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jun 15, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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