Details for New Drug Application (NDA): 065285
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The generic ingredient in DOXYCYCLINE is doxycycline hyclate. There are twenty-eight drug master file entries for this compound. Seventy-two suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
Summary for 065285
Tradename: | DOXYCYCLINE |
Applicant: | Lannett Co Inc |
Ingredient: | doxycycline |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 065285
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DOXYCYCLINE | doxycycline | TABLET;ORAL | 065285 | ANDA | Lannett Company, Inc. | 0527-1335 | 0527-1335-01 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-1335-01) |
DOXYCYCLINE | doxycycline | TABLET;ORAL | 065285 | ANDA | Lannett Company, Inc. | 0527-1338 | 0527-1338-25 | 250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-1338-25) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 50MG BASE | ||||
Approval Date: | Dec 8, 2005 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
Approval Date: | Dec 8, 2005 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 75MG BASE | ||||
Approval Date: | Jul 30, 2008 | TE: | AB | RLD: | No |
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