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CENTER FOR DRUG EVALUATION AND RESEARCH Approval Package for: APPLICATION NUMBER: ANDA 71-961Orig1/S002 Name: Sodium Nitroprusside Injection Sponsor: Hospira Approval Date: Indication: April 9, 1992 Immediate reduction of blood pressure of patients in hypertensive crises.

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Page 1: CENTER FOR DRUG EVALUATION AND RESEARCH · attecteth Sodium nitropruS¶de more act.ve on veins than ... DOSAGE section.) ... When thiosulfate is being supplied only by normal

CENTER FOR DRUG EVALUATION AND RESEARCH

Approval Package for:

APPLICATION NUMBER:

ANDA 71-961Orig1/S002

Name:

Sodium Nitroprusside Injection

Sponsor:

Hospira

Approval Date:

Indication:

April 9, 1992

Immediate reduction of blood pressure of patients in

hypertensive crises.

Page 2: CENTER FOR DRUG EVALUATION AND RESEARCH · attecteth Sodium nitropruS¶de more act.ve on veins than ... DOSAGE section.) ... When thiosulfate is being supplied only by normal

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

ANDA 71-961Orig1/S002 CONTENTS

Reviews / Information Included in this Review

Approval Letter X

Tentative Approval Letter

Labeling X

Labeling Review(s)

Medical Review(s)

Chemistry Review(s)

Pharm/Tox Review

Bioequivalence Review(s)

Statistical Review(s)

Microbiology Review(s)

Other Review(s)

Administrative & Correspondence Documents

Page 3: CENTER FOR DRUG EVALUATION AND RESEARCH · attecteth Sodium nitropruS¶de more act.ve on veins than ... DOSAGE section.) ... When thiosulfate is being supplied only by normal

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

ANDA 71-961Orig1/S002

APPROVAL LETTER

Page 4: CENTER FOR DRUG EVALUATION AND RESEARCH · attecteth Sodium nitropruS¶de more act.ve on veins than ... DOSAGE section.) ... When thiosulfate is being supplied only by normal
Page 5: CENTER FOR DRUG EVALUATION AND RESEARCH · attecteth Sodium nitropruS¶de more act.ve on veins than ... DOSAGE section.) ... When thiosulfate is being supplied only by normal

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

ANDA 71-961Orig1/S002

LABELING

Page 6: CENTER FOR DRUG EVALUATION AND RESEARCH · attecteth Sodium nitropruS¶de more act.ve on veins than ... DOSAGE section.) ... When thiosulfate is being supplied only by normal
Page 7: CENTER FOR DRUG EVALUATION AND RESEARCH · attecteth Sodium nitropruS¶de more act.ve on veins than ... DOSAGE section.) ... When thiosulfate is being supplied only by normal
Page 8: CENTER FOR DRUG EVALUATION AND RESEARCH · attecteth Sodium nitropruS¶de more act.ve on veins than ... DOSAGE section.) ... When thiosulfate is being supplied only by normal
Page 9: CENTER FOR DRUG EVALUATION AND RESEARCH · attecteth Sodium nitropruS¶de more act.ve on veins than ... DOSAGE section.) ... When thiosulfate is being supplied only by normal

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