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Details for New Drug Application (NDA): 022370
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NDA 022370 describes CONZIP, which is a drug marketed by Cipher Pharms Inc and is included in one NDA. It is available from eleven suppliers. There is one patent protecting this drug. Additional details are available on the CONZIP profile page.
The generic ingredient in CONZIP is tramadol hydrochloride. There are thirty-six drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the tramadol hydrochloride profile page.
The generic ingredient in CONZIP is tramadol hydrochloride. There are thirty-six drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the tramadol hydrochloride profile page.
Summary for 022370
| Tradename: | CONZIP |
| Applicant: | Cipher Pharms Inc |
| Ingredient: | tramadol hydrochloride |
| Patents: | 1 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 022370
| Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 022370
Suppliers and Packaging for NDA: 022370
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CONZIP | tramadol hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022370 | NDA AUTHORIZED GENERIC | Trigen Laboratories, LLC | 13811-689 | 13811-689-30 | 30 CAPSULE in 1 BOTTLE, PLASTIC (13811-689-30) |
| CONZIP | tramadol hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022370 | NDA AUTHORIZED GENERIC | Trigen Laboratories, LLC | 13811-690 | 13811-690-30 | 30 CAPSULE in 1 BOTTLE, PLASTIC (13811-690-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 100MG | ||||
| Approval Date: | May 7, 2010 | TE: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Apr 11, 2022 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | USE OF TRAMADOL FOR THE MANAGEMENT OF MODERATE TO MODERATELY SEVERE CHRONIC PAIN | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 200MG | ||||
| Approval Date: | May 7, 2010 | TE: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Apr 11, 2022 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | USE OF TRAMADOL FOR THE MANAGEMENT OF MODERATE TO MODERATELY SEVERE CHRONIC PAIN | ||||||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 300MG | ||||
| Approval Date: | May 7, 2010 | TE: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Apr 11, 2022 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | USE OF TRAMADOL FOR THE MANAGEMENT OF MODERATE TO MODERATELY SEVERE CHRONIC PAIN | ||||||||
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