DEPARTMENT
OF HEALTH AND HUMAN SERVICES FOOD AND DRUG
ADMINISTRATION APPLICATION TO MARKET A NEW DRUG, BIOLOGIC, OR AN ANTIBIOTIC DRUG FOR HUMAN USE (Title 21, Code of Federal
Regulations, Parts 314 & 601) |
Form Approved: OMB No.
0910-0338 Expiration Date: March 31, 2005 See OMB Statement on page 2 FOR
FDA USE ONLY APPLICATION NUMBER |
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APPLICANT INFORMATION |
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NAME OF APPLICANT SmithKline Beecham Corporation d/b/a
GlaxoSmithKline |
DATE OF SUBMISSION August 21, 2003 |
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TELEPHONE NO. (Include Area
Code) 919-483-2100 |
FACSIMILE (FAX) Number
(Include Area Code) (919) 483-5756 |
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APPLICANT ADDRESS (Number, Street,
City, State, Country, ZIP Code or Mail Code, and U.S. License number if
previously issued): One Franklin Plaza P.O. Box 7929 Philadelphia, PA 19101 |
AUTHORIZED U.S. AGENT NAME
& ADDRESS (Number, Street, City, State, ZIP Code, telephone & FAX
number) IF APPLICABLE |
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PRODUCT DESCRIPTION |
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NEW DRUG OR ANTIBIOTIC
APPLICATION NUMBER, OR BIOLOGICS LICENSE APPLICATION NUMBER (If previously
issued) 21-515 |
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ESTABLISHED NAME (E.G.
Proper name, USP/USAN name) Bupropion hydrochloride |
PROPRIETARY NAME (trade
name) IF ANY WELLBUTRIN XLTM |
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CHEMICAL/BIOCHEMICAL/BLOOD
PRODUCT NAME (If any) |
CODE NAME (If any) |
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DOSAGE FORM: Tablets |
STRENGTHS: 150 mg, 300 mg |
ROUTE OF ADMINISTRATION Oral |
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(PROPOSED) INDICATION(S) FOR
USE: |
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APPLICATION INFORMATION |
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APPLICATION TYPE |
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(check one) (X) NEW DRUG APPLICATION (21 CFR
314.50 ( ) ABBREVIATED NEW DRUG
APPLICATION (ANDA, 21 CFR 314.94) ( ) BIOLOGICS LICENSE
APPLICATION (21 CFR Part 601) |
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IF AN NDA, IDENTIFY THE
APPROPRIATE TYPE (X) 505
(b)(1) ( ) 505 (b)(2) |
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IF AN ANDA, OR 505(b)(2),
IDENTIFY THE REFERENCE LISTED DRUG PRODUCT THAT IS THE BASIS FOR THE
SUBMISSION Name of Drug
______________________________ Holder
of Approved Application _______________________ |
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TYPE OF SUBMISSION (check
one) ( ) ORIGINAL APPLICATION ( ) AMENDMENT TO APENDING APPLICATION ( )
RESUBMISSION ( ) PRESUBMISSION ( ) ANNUAL REPORT ( ) ESTABLISHMENT DESCRIPTION
SUPPLEMENT ( ) EFFICACY SUPPLEMENT ( ) LABELING SUPPLEMENT ( ) CHEMISTRY MANUFACTURING AND CONTROLS
SUPPLEMENT (X) OTHER |
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IF A SUBMISSION OF PARTIAL
APPLICATION, PROVIDE LETTER DATE OF AGREEMENT TO PARTIAL SUBMISSION: |
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IF A SUPPLEMENT, IDENTIFY
THE APPROPRIATE CATEGORY ( )
CBE ( ) CBE-30 ( ) PRIOR APPROVAL (PA) |
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REASON FOR SUBMISSION Response
to FDA Comment: Labeling |
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PROPOSED MARKETING STATUS (check
one) (X) PRESCRIPTION PRODUCT
RX ( ) OVER THE COUNTER PRODUCT (OTC) |
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NUMBERS OF VOLUMES
SUBMITTED _1 |
__ THIS APPLICATION IS (X)
PAPER ( ) PAPER AND ELECTRONIC ( ) ELECTRONIC |
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ESTABLISHMENT INFORMATION (Full
establishment information should be provided in the body of the Application.) Provide locations of all
manufacturing, packaging and control sites for drug substance and drug
product (continuation sheets may be used if necessary). Include name, address, contact, telephone
number, registration number (CFN), DMF number, and manufacturing steps and/or
type of testing (e.g. Final dosage form, Stability testing) conducted at the
site. Please indicate whether the site
is ready for inspection or, if not, when it will be ready. |
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Drug Product Manfacturer –
Ready for inspection GlaxoSmithKline
Contact (all other sites) Biovail Corporation, Manufacturing Division Steve
Moss, Compliance Manager, Europe/International 100 LifeSciences Parkway Harmire
Road Steinback, MB, Canada Barnard
Castle, County Durham, DL128DT, UK Contact: Hanif Sachedina, Director, Corporate
Compliance +44
(0) 183 369 0600 (416) 285-6000 x217 |
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Cross Reference (list related
License Applications, INDs, NDAs, PMAs, 510(k)s, IDEs, BMFs, and DMFs
referenced in the current application) |
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Form FDA 356h (4/00) Page 1
STAMPED:
RECEIVED AUG 22 2003 CDR/CDER
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