FDA Form 2657 Drug Product Listing (New Drug Listing)

Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution

FDA-2657

Waiver requests

OMB: 0910-0045

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Form Approved: OMB No. 0910-0045. Expiration Date: December 31, 2007. See OMB Statement on Reverse.
NAME AND ADDRESS OF FIRM

LABELING REVISON

DEPARTMENT OF HEALTH AND HUMANS SERVICES

CHANGE OF:

FOOD AND DRUG ADMINISTRATION

RTE OF ADMIN

DRUG PRODUCT LISTING

INDICATION

NAME / DOSE / STR / INGR

(In accordance with Public Law 92-387)

FOR
FDA

CONTROL NO.
1

5

RECORD ID
6

11

12

15

USE

OTHER (Specify)

NATIONAL DRUG CODE
SEC
16

17

S U
18

19

PRODUCT TRADE NAME OR CATALOG NAME

LABELER

20

83

84

PRODUCT
89

90

93

99 100

102

105 106 107

143 144

147 148

151 152

111

OTH

PT

155 156 157-158

112

SEC

S

U

16

18

19

20

17

PKG
CODE
21

22

116

PRODUCT DISCONTINUED

PROF
USE

SCHED

OTHER (Specify)

BNDD

YR

ROUTES OF ADMINISTRATION
1
2
3

DOSAGE
FORM
141

DA

PRODUCT TYPE

OTHER (Specify)

SMPL

94

MO

TYPES OF BUSINESS

TYPE
RPRT

REPORT DATE
FDA
APPLICATION NO.

LEGAL
STATUS

0 1

117 118 119 120 121

WHOLE NUMBERS

125

126

PACKAGE SIZE
23

BASIS OF CONCENTRATION

OTHER (Specify)

133 134

48

72

0 3

159

161

MOST RECENT
MARKETING DATE
MO
YEAR

164 165

167

DISCONTINUED
DATE
MO
YEAR

170 171

173

176

0 3
0 3

S U

TYPE

0 3
SEC
16

18

20

17

19

PT
21

22

137 138

140

PACKAGE TYPE
47

0 3
INITIAL
MARKETING DATE
MO
YEAR

UNIT

DECIMAL

44

AMOUNT
WHOLE NUMBER

FDA USE ONLY
INGREDIENT NO.

ESTABLISHED NAME OF PRODUCT AND / OR INGREDIENT(S) OR BIOLOGIC PROPER NAME, TEST OBJECTIVE / EQUIPMENT / REAGENT NAME, ETC.

100 23

28

29

35

NOTICE: This report
is required by law
(21 C.F.R. 207.20).
Failure to report can
result in imprisonment
for not more than one
year or a fine of not
more than $1,000, or
both (FDA&C Act,
Section 303).

UNIT

DECIMAL
37

40

41

43

0 5
0 5
0 5
0 5
0 5
0 5
0 5
0 5
0 5
0 5
SEC

S U

16

18

17

19

SITE OR FIRM ESTABLISHMENT
REGISTRATION NUMBER

20

ACTUAL MANUFACTURING SITE OF THE ABOVE DRUG PRODUCT
29

30

FOREIGN COUNTRY

STATE
68

69

70

71

SHORT NAME

NDC LABELER CODE
80

81

86

87

101

0 7
0 7
0 7
FORM FDA 2657 (8 /07)

PREVIOUS EDITION IS OBSOLETE.

PSC Graphics: (301) 443-1090

EF

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Public reporting burden for this collection of information is estimated to average 30 minutes per response, including the time for reviewing
instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of
information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing
this burden to:
Food and Drug Administration
CDER/Drug Registration and Listing (HFD-337)
5600 Fishers Lane
Rockville, MD 20857

An agency may not conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB control number.

FOLD HERE

FOLD HERE

Please fold form where indicated, place in a window
envelope, and return to address indicated.
RETURN THIS FORM TO:
FOOD AND DRUG ADMINISTRATION
CDER/DRUG REGISTRATION AND LISTING (HFD-337)
5600 FISHERS LANE
ROCKVILLE, MD 20857

Food and Drug Administration
CDER/Drug Registration and Listing (HFD-337)
5600 Fishers Lane
Rockville, MD 20857

FOLD HERE

FOLD HERE

If using Federal Express, DHL or any special carrier to return this form, please use the
following address:
(Please refer to the Drug Registration and Listing Booklet.)

When completing this form, please refer to the Drug Registration and Listing Instruction Booklet for assistance.
PLEASE PRINT IN ENGLISH USING BLACK INK.

FOLD HERE

FOLD HERE

FORM FDA 2657 (8/07) (BACK)


File Typeapplication/pdf
File Titleuntitled
File Modified2007-12-03
File Created2007-09-06

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