NDC Code(s) : 0430-0112-24, 0430-0112-96, 0430-0115-95, 0430-0115-20, 0430-0114-20, 0430-0114-95
Packager : Allergan, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DORYXdoxycycline hyclate TABLET, DELAYED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0430-0112
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXYCYCLINE HYCLATE(UNII: 19XTS3T51U)
(DOXYCYCLINE ANHYDROUS - UNII:334895S862) 		DOXYCYCLINE ANHYDROUS100 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
TALC(UNII: 7SEV7J4R1U)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
STARCH, CORN(UNII: O8232NY3SJ)
CROSPOVIDONE(UNII: 2S7830E561)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE (containing yellow pellets) Score 2 pieces
Shape OVAL Size 17 mm
Flavor Imprint Code D;1
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0430-0112-2448 in 1 CASE 01/09/2005
1100 in 1 BOTTLE Type 0: Not a Combination Product
2NDC:0430-0112-9648 in 1 CASE 01/09/2005
21 in 1 CARTON 01/09/2005
23 in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050795 09/01/2005 08/01/2011
DORYXdoxycycline hyclate TABLET, DELAYED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0430-0115
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXYCYCLINE HYCLATE(UNII: 19XTS3T51U)
(DOXYCYCLINE ANHYDROUS - UNII:334895S862) 		DOXYCYCLINE ANHYDROUS150 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
TALC(UNII: 7SEV7J4R1U)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
STARCH, CORN(UNII: O8232NY3SJ)
CROSPOVIDONE(UNII: 2S7830E561)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE (containing yellow pellets) Score 3 pieces
Shape RECTANGLE Size 18 mm
Flavor Imprint Code D;D;D
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0430-0115-9548 in 1 CASE 21/09/2011
11 in 1 CARTON
13 in 1 BOTTLE Type 0: Not a Combination Product
2NDC:0430-0115-2048 in 1 CASE 21/09/2011
260 in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050795 09/21/2011 01/31/2013
DORYXdoxycycline hyclate TABLET, DELAYED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0430-0114
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXYCYCLINE HYCLATE(UNII: 19XTS3T51U)
(DOXYCYCLINE ANHYDROUS - UNII:334895S862) 		DOXYCYCLINE ANHYDROUS200 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
TALC(UNII: 7SEV7J4R1U)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
STARCH, CORN(UNII: O8232NY3SJ)
CROSPOVIDONE(UNII: 2S7830E561)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE (containing yellow pellets) Score 2 pieces
Shape OVAL Size 19 mm
Flavor Imprint Code D;D
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0430-0114-2048 in 1 CASE 01/07/2013
160 in 1 BOTTLE Type 0: Not a Combination Product
2NDC:0430-0114-9548 in 1 CASE 01/07/2013
21 in 1 CARTON 01/07/2013
23 in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050795 07/01/2013 04/30/2016

PRINCIPAL DISPLAY PANEL

DORYX® (Doxycycline Hyclate Delayed-Release Tablets, USP), 100 mg Trade Label

N 0430-0112-24

DORYX®
(Doxycycline Hyclate Delayed-Release Tablets, USP)

100 mg

Rx only

Each tablet contains specially coated pellets of doxycycline hyclate equivalent to 100 mg of doxycycline.

100 TABLETS
DORYX® (Doxycycline Hyclate Delayed-Release Tablets, USP), 100 mg Trade Label

US Patent No. 6,958,161

PRINCIPAL DISPLAY PANEL

DORYX® (doxycycline hyclate) Delayed-Release Tablets, 100 mg Sample Carton

N 0430-0112-96

NEW TABLET DESIGN

NEW TABLET IMPRINT

DORYX®
(doxycycline hyclate)
Delayed-Release Tablets

100 mg

Rx only

Physician's Sample - NOT FOR SALE

3 Tablets

US Patent No. 6,958,161
DORYX® (doxycycline hyclate) Delayed-Release Tablets, 100 mg Sample Carton

PRINCIPAL DISPLAY PANEL

DORYX® (doxycycline hyclate delayed-release tablets, USP) 150 mg trade label

N 0430-0115-20

DORYX®
(doxycycline hyclate delayed-release tablets, USP)

150 mg

Do not chew or crush tablets.

Each tablet contains specially coated pellets of doxycycline hyclate equivalent to 150 mg of doxycycline.

Rx only

60 TABLETS
DORYX® (doxycycline hyclate delayed-release tablets, USP) 150 mg trade label

US Patent No. 6,958,161

PRINCIPAL DISPLAY PANEL

DORYX® (doxycycline hyclate delayed-release tablets, USP) 150 mg sample carton label

N 0430-0115-95

DORYX®
(doxycycline hyclate delayed-release tablets, USP)

150 mg per tablet

Take with adequate amounts of fluid
Do not chew or crush tablets

Rx only

Physician's Sample - NOT FOR SALE

3 TABLETS

US Patent No. 6,958,161
DORYX® (doxycycline hyclate delayed-release tablets, USP) 150 mg sample carton label

PRINCIPAL DISPLAY PANEL

DORYX® (doxycycline hyclate delayed-release tablets, USP) 200 mg trade bottle label

N 0430-0114-20

NEW STRENGTH

DORYX®
(doxycycline hyclate delayed-release tablets)

200 mg

Rx only

Each tablet contains specially coated pellets of doxycycline hyclate equivalent to 200 mg of doxycycline.

60 TABLETS

To report SUSPECTED ADVERSE REACTIONS, contact Warner Chilcott at 1-800-521-8813 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
DORYX® (doxycycline hyclate delayed-release tablets, USP) 200 mg trade bottle label

US Patent No. 6,958,161

PRINCIPAL DISPLAY PANEL

DORYX® (doxycycline hyclate delayed-release tablets, USP) 200 mg sample carton label

N 0430-0114-95

NEW STRENGTH

DORYX®
(doxycycline hyclate delayed-release tablets)

200 mg

Rx only

Physician's Sample - NOT FOR SALE

3 TABLETS

To report SUSPECTED ADVERSE REACTIONS, contact Warner Chilcott at 1-800-521-8813 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
DORYX® (doxycycline hyclate delayed-release tablets, USP) 200 mg sample carton label

US Patent No. 6,958,161