Section vi section 6

International Journal of Generic Drugs
SECTION II SECTION 2
TABLE OF CONTENTS
(Overall ANDA Guideline Requirements for this Section). 2.O Section Page and Title. The information in this section summarizes the four critical structures supporting the legal basis for this abbreviated new drug application 2.1.0 Basis for ANDA Submission is submitted as follows and is; 2.1.1 Based on an Abbreviated New Drug Application 2.1.2 Based on an approved ANDA Suitability Petition 3.0 Based on Active Ingredient (same as RLD) and current approved labeling 4.0 Based on Route of Administration, Dosage Form and Strength 5.0 Based on Bioequivalency Data submitted (Applicant Generic Drug vs. RLD) NOTE:- MODEL Letters are provided in Section IV highlighting each of four critical structures and supporting documentation stating the legal basis for this abbreviated new drug application International Journal of Generic Drugs
SECTION II SECTION 2

BASIS FOR ABBREVIATED NEW DRUG APPLICATION
[a] Listed Drug.
This applications refers to the Reference Listed Drug [NAME]
Capsule manufactured by [RLD Company Name Inc. / Ltd.].

The basis for [Applicant Company Name Inc. / Ltd.] proposed ANDA for Full
Generic Drug Name is the approved reference listed drug as above, the subject of
ANDA [#00 0000] held by [RLD Company Name Inc. / Ltd.]. and containing [000.0 /
000.0 / 000.0mg] of [Generic Drug Name].
According to the FDA listed information published in the list of approved Drug
Products known as the Orange Book 20th (2000) Edition the listing is enclosed
herewith.
[b] Exclusivity.
Furthermore according to the FDA listed information published in the list of
Approved Drug Products [Orange Book] 20th (2000) Edition the RLD is entitled to a
period of marketing exclusivity (under section 505j[4][D] of the Act as a New
Chemical Entity until the NCE's expiration period of MM/DD/YY
Furthermore according to the FDA listed information published in the list of
Approved Drug Products [Orange Book] 20th (2000) Edition, no exclusivity’s for
the listed the RLD applies.
[c] According to the information published in the 20th Edition List (2000),
the reference listed drug is covered by [one / two] use patent which is
addressed in Section III of this application.
[d] APPROVED ANDA SUITABILITY PETITION
The basis for [Applicant Company Name Inc. / Ltd.] proposed ANDA is further
based on the approval of the suitability petition pursuant to the 21 Code Federal
Register (CFR) # 505[j][2][c] and 21 CFR 314.93 that requested a change from the
above listed drug in subparagraph 1[a] as above.
Docket No [00000]
The basis of this ANDA SUITABILITY PETITION is held and was submitted under
Docket No [00000] and approved on MM/DD/YY.

A copy of the FDA letter approving the ANDA SUITABILITY PETITION is attached in
section II of this application (page [00])
SECTION II SECTION 2

BASIS FOR ABBREVIATED NEW DRUG APPLICATION (continued)

ACTIVE INGREDIENT [00000]
21 CFR 314.94 [A][5][i]
he active ingredient of [Applicant Company Name Inc. / Ltd.] Generic Tablet
/
T Capsule is the same as that of the RLD brand name
We refer the reviewer to [Applicant Company Name Inc. / Ltd.] annotated labeling
and the current approved labeling of the RLD as shown in Section IV-05 of this
ANDA (Refer pages [00] to [00])
ROUTE OF ADMINISTRATION DOSAGE FORM AND STRENGTH
21 CFR 314.94 [A][5][i]
he Route of Administration, Dosage Form and Strength [Applicant Company's
Name Inc. / Ltd.] of
Tablet / Capsule is the same as for [RLD
brand name]
Again we refer the reviewer to [Applicant Company Name Inc. / Ltd.] annotated
labeling and the current approved labeling of the RLD as shown in Section IV-05 of
this ANDA (Refer pages [00] to [00])
BIOEQUIVALENCY DATA [00000]
21 CFR 314.94 [A][7][i]

[Applicant Company Name Inc. / Ltd.] bioequivalent study on [Generic
Capsule Name] was successfully conducted in terms of current approval
parameters by Clinical Research Laboratories [Name and Address]
The Full Bioequivalence Report is attached to Section VI of this ANDA (Refer pages
[000] to [000])
[Signature of Responsible Person]
------------------------------------------------
----------------------------------------- [Name of Responsible Person] Date
Regulatory Affairs Director
[Applicant Company Name Inc. / Ltd.]
[Signature of Responsible Person]
[Two typical examples of this section are given below] SECTION II SECTION 2

Listed Drug.
This applications refers to the Reference Listed Drug [RLD] Imodium 1/
Imodium 2 Generic
Tablet / Capsule manufactured by [RLD
Company Name Inc. / Ltd.]3.
A copy of the Orange Book 20th (2000) Edition listing is enclosed
herewith.
According to the information published in the 20th Edition List, the
reference listed drug is covered by [ no / one / two] use patent which
is addressed in Section III of this application.
Exclusivity.
There are [ONE] / [two] / [no] exclusivity’s for the listed drug.
I-184 - expires Sept 24, 2000
I-185 - expires Sept 24, 2000
[Signature of Responsible Person]
------------------------------------------------
---------------------------------------- ------------------------------------------ [Name of Responsible Person] Date
Regulatory Affairs Director
[Applicant Company Name Inc. / Ltd.]

[Signature of Responsible Person]
------------------------------------------------
----------------------------------------- ----------------------------------------- [Name of Responsible Person] Date
Regulatory Affairs Director
[Applicant Company Name Inc. / Ltd.]

1INNOVATOR NAME COUNTRY US or EU
2USA RLD 375 / 500 mg - Application Number 000000 SECTION II SECTION 2

Listed Drug.
This applications refers to the Reference Listed Drug [RLD] Imodium1/
Imodium2
Tablet / Capsule manufactured by [RLD Innovator
Company Name Inc. / Ltd.]3.
A copy of the Orange Book 20th (2000) Edition listing is enclosed
herewith.
According to the information published in the 20th Edition List (2000),
the reference listed drug [RLD] is covered by [ no / one /two] use
patent(s) which is addressed in Section III of this application.
Exclusivity.
According to the information published in the 20th Edition of the Orange
Guide (2000), there are [one] / [two] /
[no] exclusivity’s for the listed
drug. I-000 - expires MM DD, 2000 I-000 - expires MM DD, 2000 [Signature of Responsible Person] ------------------------------------------------ ----------------------------------------- ----------------------------------------- [Name of Responsible Person] Date
Regulatory Affairs Director
[Applicant Company Name Inc. / Ltd.]

[Signature of Responsible Person]
------------------------------------------------
----------------------------------------- ----------------------------------------- [Name of Responsible Person] Date
Regulatory Affairs Director
[Applicant Company Name Inc. / Ltd.]

1 INNOVATOR
2 USA RLD IS REGISTERED AS STRENGTH 0 mg +00 mg
INNOVATOR Application Number [00000]
3 INNOVATOR
SECTION II SECTION 2

ANDA SUITABILITY PETITION APPROVAL LETTER
Date:
Office of Generic Drugs
CDER, Food and Drug Administration
Document Control Room - No. 150
Metro Park North II
7500 Standish Place
ROCKVILLE MD 20855-2773.
ORIGINAL ABBREVIATED NEW DRUG APPLICATION
[Generic name] Oral Tablets/Capsules

Dear Sir,
We submit herewith the ANDA SUITABILITY PETITION APPROVAL LETTER
for the drug product [Generic name Tablet / Capsule [000 / 000] mg.
[Signature of Responsible Person]
------------------------------------------------
----------------------------------------- ----------------------------------------- [Name of Responsible Person] Date
Regulatory Affairs Director
[Applicant Company Name Inc. / Ltd.]

[ANDA SUITABILITY PETITION APPROVAL LETTER

Source: http://iagim.org/pdf/guide08.pdf