Minds On Meds

Mental Health Medications

Antidepressants

Emsam, Page 7

Emsam (selegiline transdermal system) is a transdermally administered antidepressant. When applied to intact skin, Emsam is designed to continuously deliver selegiline over a 24-hour period. Emsam is indicated for the treatment of major depressive disorder.


2

Adapted from K.I. Shulman, S.E. Walker, Psychiatric Annals 2001; 31:378-384

PRINCIPAL DISPLAY PANEL — 6 mg/24 h

NDC-49502-900-30

EACH UNIT DOSE PACKAGE IS NOT CHILD RESISTANT
Rx only

EMSAM®
(selegiline transdermal system)
6 mg/24 h

FOR TRANSDERMAL USE ONLY

Patient: Read enclosed Medication Guide.

Pharmacist: Dispense with enclosed
Medication Guide.

30 TRANSDERMAL
SYSTEMS

INSTRUCTIONS FOR APPLICATION

  1. Select and prepare an appropriate site on the (A) upper chest or back (below the neck and above the waist), (B) upper thigh, or (C) outer surface of the upper arm, as directed in the enclosed Medication Guide.
  2. Bend both sides of the clear peelable liner. Peel off one strip only of the clear liner. Avoid touching the sticky side of the transdermal system.
  3. Apply sticky side of the transdermal system to the chosen skin site. Remove remaining strip, gently roll remaining part onto skin, and press transdermal system firmly in place with the tips of your fingers.

For more detailed instructions, read enclosed Medication Guide.

Dosage application 6 mg/24 h carton
(click image for full-size original)

Dosage: Apply one (1) transdermal system every 24 hours. Read enclosed Medication Guide.

Each transdermal system has a release rate of 6 mg selegiline per 24 hour period. Wear only one transdermal system at a time.

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Distributed by
Dey Pharma, L.P.
Napa, CA 94558

Manufactured for
Somerset
Pharmaceuticals, Inc.
Morgantown, WV 26505

Rx only

EMSAM Transdermal System 6 mg/24 h Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 9 mg/24 h

NDC-49502-901-30

EACH UNIT DOSE PACKAGE IS NOT CHILD RESISTANT
Rx only

EMSAM®
(selegiline transdermal system)
9 mg/24 h

Important: Do not eat certain foods.
Read enclosed Medication Guide.

FOR TRANSDERMAL USE ONLY

Pharmacist: Dispense with enclosed
Medication Guide.

30 TRANSDERMAL
SYSTEMS

INSTRUCTIONS FOR APPLICATION

  1. Select and prepare an appropriate site on the (A) upper chest or back (below the neck and above the waist), (B) upper thigh, or (C) outer surface of the upper arm, as directed in the enclosed Medication Guide.
  2. Bend both sides of the clear peelable liner. Peel off one strip only of the clear liner. Avoid touching the sticky side of the transdermal system.
  3. Apply sticky side of the transdermal system to the chosen skin site. Remove remaining strip, gently roll remaining part onto skin, and press transdermal system firmly in place with the tips of your fingers.

For more detailed instructions, read enclosed Medication Guide.

Dosage application 9 mg/24 h carton
(click image for full-size original)

Dosage: Apply one (1) transdermal system every 24 hours. Read enclosed Medication Guide.

Each transdermal system has a release rate of 9 mg selegiline per 24 hour period. Wear only one transdermal system at a time.

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Distributed by
Dey Pharma, L.P.
Napa, CA 94558

Manufactured for
Somerset
Pharmaceuticals, Inc.
Morgantown, WV 26505

Rx only

EMSAM Transdermal System 9 mg/24 h Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 12 mg/24 h

NDC-49502-902-30

EACH UNIT DOSE PACKAGE IS NOT CHILD RESISTANT
Rx only

EMSAM®
(selegiline transdermal system)
12 mg/24 h

Important: Do not eat certain foods.
Read enclosed Medication Guide.

FOR TRANSDERMAL USE ONLY

Pharmacist: Dispense with enclosed
Medication Guide.

30 TRANSDERMAL
SYSTEMS

INSTRUCTIONS FOR APPLICATION

  1. Select and prepare an appropriate site on the (A) upper chest or back (below the neck and above the waist), (B) upper thigh, or (C) outer surface of the upper arm, as directed in the enclosed Medication Guide.
  2. Bend both sides of the clear peelable liner. Peel off one strip only of the clear liner. Avoid touching the sticky side of the transdermal system.
  3. Apply sticky side of the transdermal system to the chosen skin site. Remove remaining strip, gently roll remaining part onto skin, and press transdermal system firmly in place with the tips of your fingers.

For more detailed instructions, read enclosed Medication Guide.

Dosage application 12 mg/24 h carton
(click image for full-size original)

Dosage: Apply one (1) transdermal system every 24 hours. Read enclosed Medication Guide.

Each transdermal system has a release rate of 12 mg selegiline per 24 hour period. Wear only one transdermal system at a time.

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Distributed by
Dey Pharma, L.P.
Napa, CA 94558

Manufactured for
Somerset
Pharmaceuticals, Inc.
Morgantown, WV 26505

Rx only

EMSAM Transdermal System 12 mg/24 h Carton
(click image for full-size original)
EMSAM
selegiline patch
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49502-900
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SELEGILINE (SELEGILINE) SELEGILINE 6 mg in 24 h
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49502-900-30 30 POUCH (POUCH) in 1 CARTON contains a POUCH (49502-900-01)
1 NDC:49502-900-01 1 PATCH (PATCH) in 1 POUCH This package is contained within the CARTON (49502-900-30) and contains a PATCH
1 24 h in 1 PATCH This package is contained within a POUCH (49502-900-01) and a CARTON (49502-900-30)
2 NDC:49502-900-05 5 POUCH (POUCH) in 1 CARTON contains a POUCH (49502-900-11)
2 NDC:49502-900-11 1 PATCH (PATCH) in 1 POUCH This package is contained within the CARTON (49502-900-05) and contains a PATCH
2 24 h in 1 PATCH This package is contained within a POUCH (49502-900-11) and a CARTON (49502-900-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021336 06/30/2010
EMSAM
selegiline patch
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49502-901
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SELEGILINE (SELEGILINE) SELEGILINE 9 mg in 24 h
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49502-901-30 30 POUCH (POUCH) in 1 CARTON contains a POUCH (49502-901-01)
1 NDC:49502-901-01 1 PATCH (PATCH) in 1 POUCH This package is contained within the CARTON (49502-901-30) and contains a PATCH
1 24 h in 1 PATCH This package is contained within a POUCH (49502-901-01) and a CARTON (49502-901-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021336 06/30/2010
EMSAM
selegiline patch
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49502-902
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SELEGILINE (SELEGILINE) SELEGILINE 12 mg in 24 h
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49502-902-30 30 POUCH (POUCH) in 1 CARTON contains a POUCH (49502-902-01)
1 NDC:49502-902-01 1 PATCH (PATCH) in 1 POUCH This package is contained within the CARTON (49502-902-30) and contains a PATCH
1 24 h in 1 PATCH This package is contained within a POUCH (49502-902-01) and a CARTON (49502-902-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021336 06/30/2010
Labeler — Dey Pharma, L.P. (194775557)
Registrant — Somerset Pharmaceuticals, Inc (154311393)
Establishment
Name Address ID/FEI Operations
Mylan Technologies Inc. 063790265 MANUFACTURE, ANALYSIS

Revised: 01/2010 Dey Pharma, L.P.