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pdf[Company]
1
A
Brand-Name Drug
with Putative AG
List A--Putative AG Drugs
B
Active ingredient
FTC Authorized Generic Drug Study
Question 4
C
AG?
(Yes/No)
Page 1 of 8
OMB Control No. [insert]
[Company]
A
B
Brand-Name Active Ingredient
of Drug
Subject to ¶ 4
List B--Brand-Name Drugs Subject to Paragraph IV Certifications
C
Dosage
Form
D
NDA #
Question 5
E
F
Dosage
AG?
Strength (Yes/No)
1
FTC Authorized Generic Drug Study
Page 2 of 8
OMB Control No. [insert]
[Company]
A
B
AG Trade Brand-Name
Name, if
any
Authorized Generic Drug List and Information
C
Active Ingredient
1
FTC Authorized Generic Drug Study
D
Dosage
Form
E
NDA #
Questions 6, 7, 8, 9, 10, 11
F
G
H
I
J
NDC Date of
Dosage NDA Date AG - 9 digit NDC Date
of
Discontinuance, if
Strength
of
NDC #
Launch
any
Approval (Labeler
(for each
Code strength)
Product
Code)
Page 3 of 8
OMB Control No. [insert]
[Company]
1
H
AG - 9 digit
NDC #
(Labeler
Code Product
Code)
Authorized Generic Drug List and Information
K
AG Labeler/Entity
Name
FTC Authorized Generic Drug Study
L
M
N
AG
AG Labeler/
QUESTION 7
Coordinate
Labeler/Entity
Marketing
with
Relationship to Entity Address
marketing
Company
& Phone
entity?
(Yes/No)
Page 4 of 8
Questions 6, 7, 8, 9, 10, 11
O
P
Q
STOP!!
QUESTION 10 QUESTION 11
Date of first
Settlement
FILL IN
agreement
COLUMNS P announcement
of AG marketing related to AG
& Q WITH
marketing?
PART III.
(Yes/No)
OMB Control No. [insert]
[Company]
A
Brand-Name (AG
version marketed)
Information on Brand-Name Drugs for Which an AG Was Marketed
B
Active
Ingredient
1
FTC Authorized Generic Drug Study
C
Dosage
Form
D
NDA #
E
F
G
9 digit
Dosage
NDA
Strength Approval NDC #
Date (for (Labeler
Code each
strength) Product
Code)
Page 5 of 8
H
Labeler/Entity Name
Question 12
I
Labeler/Entity
Relationship to
Company
J
Therapeutic
Category
OMB Control No. [insert]
[Company]
A
K
Brand-Name (AG Pharmacological
version marketed)
Class
1
FTC Authorized Generic Drug Study
Information on Brand-Name Drugs for Which an AG Was Marketed
L
14-Digit Generic
Product Identifier
Question 12
M
N
O
P
Q
Generic
Name of
Name of ANDA- Name of ANDADate of
entry via 180ANDAGeneric
first
Generic
Generic
Company #1
ANDACompany #2
day
Company #3
During
generic exclusivity?
During
During
Exclusivity
entry (or
Exclusivity
(Yes/No)
Exclusivity
"none")
Page 6 of 8
R
Enter columns
for additional
companies
here►►
OMB Control No. [insert]
[Company]
A
Brand-Name (¶ IVno AG marketed)
Brand-Name Drugs--Subject to Paragraph IV; No AG Marketed
B
Active Ingredient
C
Dosage
Form
D
NDA #
E
F
G
9 digit
Dosage
NDA
Strength Approval NDC #
Date (for (Labeler
Code each
strength) Product
Code)
H
Labeler/Entity Name
Questions 13, 14
I
Labeler/Entity
Relationship to
Company
1
FTC Authorized Generic Drug Study
Page 7 of 8
OMB Control No. [insert]
[Company]
A
Brand-Name (¶ IVno AG marketed)
Brand-Name Drugs--Subject to Paragraph IV; No AG Marketed
J
K
Therapeutic PharmaCategory
cological
Class
L
14-Digit
Generic
Product
Identifier
Questions 13, 14
M
N
O
P
Q
R
S
Question 14
Enter
Name of
Generic
Name of
Date of
Name of
ANDA- columns for
entry via 180- ANDAANDAfirst
AG NOT
additional Marketed Per
Generic
Generic
ANDAGeneric
day
generic exclusivity? Company #1 Company Company companies Settlement
here►►
#2 During #3 During
entry (or
During
(Yes/No)
Agreement
"none")
Exclusivity Exclusivity Exclusivity
(Yes/NO)
1
FTC Authorized Generic Drug Study
Page 8 of 8
OMB Control No. [insert]
File Type | application/pdf |
File Title | Example-FTC provides SO to Brand-4-17-blank.xls |
Author | kgoldman |
File Modified | 2007-05-04 |
File Created | 2007-05-04 |