Companies providing information on over 10 drug products

[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 #

F
G
H
Dosage 14-Digit Generic AG - 9 digit
Strength
Product
NDC #
Identifier
(Labeler
Code Product
Code)

Page 1 of 6

Questions 4, 5, 6

I
AG Labeler/Entity
Name

OMB Control No. [insert]

[Company]

1

Authorized Generic Drug List and Information

J
K
L
M
H
AG - 9 digit NDC Date
NDC Date of
Date of first
Has Company
of
NDC #
Discontinuance, if announcement
marketed this
Launch
(Labeler
any
of AG marketing drug as an ANDA
Code generic?
Product
(Yes/No)
Code)

FTC Authorized Generic Drug Study

Page 2 of 6

Questions 4, 5, 6

N
QUESTION 6
AG marketed
pursuant to
settlement?
(Yes/No)

OMB Control No. [insert]

[Company]

List of ANDA-Generic Drugs (Brand Subject to ¶ IV or AG Marketed by Any Company) and Information

A
B
Brand-Name of NDA #
Drug Subject to of RLD
¶ 4 or Drug with
AG marketed by
Any Company

C
Active
Ingredient

1

FTC Authorized Generic Drug Study

D
Dosage
Form

E
F
ANDA Dosage
#
Strength

Question 7

G
H
I
J
K
180-day
NDC Date of
9 digit Labeler/Entity Name NDC Date
of Launch Discontinuance, if exclusivity?
NDC #
(Yes/No)
any
(Labeler
Code Product
Code)

Page 3 of 6

OMB Control No. [insert]

[Company]

1

G
9 digit
NDC #
(Labeler
Code Product
Code)

List of ANDA-Generic Drugs (Brand Subject to ¶ IV or AG Marketed by Any Company) and Information

L
Date 180-day
exclusivity
began

FTC Authorized Generic Drug Study

M
Date 180-day
exclusivity
ended

N
O
P
Name of ANDA- Name of ANDAName of
Generic
ANDAGeneric
Company #2
Generic
Company #3
During
Company #4
During
Exclusivity
During
Exclusivity
Exclusivity

Page 4 of 6

Question 7

Q
Enter columns
for additional
companies
here►►

OMB Control No. [insert]

[Company]

A
Active Ingredient

1

ANDA-Generic Drugs--Additional Information

B
C
D
E
F
G
14-Digit
Dosage ANDA # Dosage Date of Date of
Generic
ANDA
Form
Strength ANDA
Filing Approval Product
Identifier
for
Dosage
Strength

FTC Authorized Generic Drug Study

Page 5 of 6

H
Patent
Number

Question 8

I
J
K
L
Date of
Paragraph # Date of Patent Paragraph #
Amended
Certification of Amended
of
Certification
Patent
Certification
Certification

OMB Control No. [insert]

[Company]

C
ANDA #

ANDA-Generic Drugs--Additional Information

M
Patent
Number

N
Paragraph #
of
Certification

1

FTC Authorized Generic Drug Study

Question 8

O
P
Q
R
Enter sets
Date of
Paragraph #
Date of
of columns
of Amended Amended
Patent
for
Certification
Patent
Certification
additional
Certification
patents
here►►

Page 6 of 6

OMB Control No. [insert]