Companies providing information on 1-5 drug products

[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

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