Details for New Drug Application (NDA): 065454
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The generic ingredient in DOXYCYCLINE is doxycycline hyclate. There are twenty-eight drug master file entries for this compound. Seventy-three suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
Summary for 065454
Tradename: | DOXYCYCLINE |
Applicant: | Chartwell |
Ingredient: | doxycycline |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 065454
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DOXYCYCLINE | doxycycline | FOR SUSPENSION;ORAL | 065454 | ANDA | Chartwell RX LLC | 62135-417 | 62135-417-46 | 60 mL in 1 BOTTLE, GLASS (62135-417-46) |
DOXYCYCLINE | doxycycline | FOR SUSPENSION;ORAL | 065454 | ANDA | Chartwell RX LLC | 62135-877 | 62135-877-46 | 60 mL in 1 BOTTLE, GLASS (62135-877-46) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 25MG BASE/5ML | ||||
Approval Date: | Jul 16, 2008 | TE: | AB | RLD: | No |
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