Details for New Drug Application (NDA): 050641
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NDA 050641 describes MONODOX, which is a drug marketed by Chartwell Rx and is included in one NDA. It is available from two suppliers. Additional details are available on the MONODOX profile page.
The generic ingredient in MONODOX is doxycycline. There are twenty-eight drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the doxycycline profile page.
The generic ingredient in MONODOX is doxycycline. There are twenty-eight drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the doxycycline profile page.
Summary for 050641
| Tradename: | MONODOX |
| Applicant: | Chartwell Rx |
| Ingredient: | doxycycline |
| Patents: | 0 |
Suppliers and Packaging for NDA: 050641
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MONODOX | doxycycline | CAPSULE;ORAL | 050641 | NDA | Chartwell RX, LLC. | 62135-260 | 62135-260-01 | 100 CAPSULE in 1 BOTTLE (62135-260-01) |
| MONODOX | doxycycline | CAPSULE;ORAL | 050641 | NDA | Chartwell RX, LLC. | 62135-261 | 62135-261-01 | 100 CAPSULE in 1 BOTTLE (62135-261-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Dec 29, 1989 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | Feb 10, 1992 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 75MG BASE | ||||
| Approval Date: | Oct 18, 2006 | TE: | AB | RLD: | Yes | ||||
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