DIVISION OF
NEUROPHARMACOLOGICAL DRUG PRODUCTS
Review of Chemistry,
Manufacturing, and Controls
NDA#: 20-358 |
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CHEMISTRY REVIEW#: 1 |
DATE REVIEWED: 15-AUG-94 |
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SUBMISSION TYPE |
DOCUMENT DATE |
CDER
DATE |
ASSIGNED DATE |
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ORIGINAL |
13-APR-93 |
13-APR-93 |
21-APR-93 |
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RESUBMITTED |
28-FEB-94 |
28-FEB-94 |
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NAME & ADDRESS OF APPLICANT |
BURROUGHS WELLCOME COMPANY |
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3030 Cornwallis Road |
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Research Triangle Park, NC 27709 |
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DRUG PRODUCT NAME |
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Proprietary: |
WELLBUTRIN® SR |
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Nonproprietary/Established/USAN: |
Bupropion hydrochloride |
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Code
Name/#: |
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Chem.
Type/Ther. Class |
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ANDA Suitability Petition / DESI / Patent Status: |
N/A |
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PHARMACOLOGICAL CATEGORY/INDICATION: |
ANTIDEPRESSANT/DEPRESSION |
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DOSAGE FORM: |
TABLETS |
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STRENGTHS: |
50, 100 and 150mg |
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ROUTE OF ADMINISTRATION: |
Oral |
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DISPENSED: |
XX Rx
___OTC |
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CHEMICAL NAME, STRUCTURAL FORMULA, MOLECULAR
FORMULA, MOLECULAR WEIGHT: |
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2-tert-butylamino-3’-chloropropiophenone
hydrochloride (±) |
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CAS #: 31677-93-7; 34911-55-2 (bupropion base) |
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Molecular Formula: C13H18CINO.
HCl |
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Moleculary Weight: 276.21 |
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WELLBUTRIN (Bupropion hydrochloride) |
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CONCLUSIONS & RECOMMENDATIONS: |
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Based on review of the Chemistry and Manufacturing
Controls Section of this submission, recommend that submission be considered
UNAPPROVABLE until validation of the regulatory test methods, satisfactory
EER and EA and satisfactory response to chemist’s deficiency letter are
completed or implemented. |
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cc:
Org. NDA 20-358
HFD-120/Division File
HFD-120/CPBarisek/8/15/94
HFD_120/David
HFD-120/SBlum
HFD-102/Ckumkumian [#1 only] (signature
dated 9/19/94)
R/D Init by: SBlum Charles
B. Parisek, Ph.D., Review Chemist
filename: NO20358.000
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