Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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U.S. Department of Health and Human Services

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Search results from the "OB_Rx" table for query on "020616."



Active Ingredient: MORPHINE SULFATE
Dosage Form;Route: CAPSULE, EXTENDED RELEASE;ORAL
Proprietary Name: KADIAN
Applicant: WATSON LABS INC
Strength: 20MG
Application Number: N020616
Product Number: 001
Approval Date: Jul 3, 1996
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB1
Patent and Exclusivity Info for this product: View

Active Ingredient: MORPHINE SULFATE
Dosage Form;Route: CAPSULE, EXTENDED RELEASE;ORAL
Proprietary Name: KADIAN
Applicant: WATSON LABS INC
Strength: 50MG
Application Number: N020616
Product Number: 002
Approval Date: Jul 3, 1996
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB1
Patent and Exclusivity Info for this product: View

Active Ingredient: MORPHINE SULFATE
Dosage Form;Route: CAPSULE, EXTENDED RELEASE;ORAL
Proprietary Name: KADIAN
Applicant: WATSON LABS INC
Strength: 100MG
Application Number: N020616
Product Number: 003
Approval Date: Jul 3, 1996
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code: AB1
Patent and Exclusivity Info for this product: View

Active Ingredient: MORPHINE SULFATE
Dosage Form;Route: CAPSULE, EXTENDED RELEASE;ORAL
Proprietary Name: KADIAN
Applicant: WATSON LABS INC
Strength: 30MG
Application Number: N020616
Product Number: 004
Approval Date: Mar 9, 2001
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB1
Patent and Exclusivity Info for this product: View

Active Ingredient: MORPHINE SULFATE
Dosage Form;Route: CAPSULE, EXTENDED RELEASE;ORAL
Proprietary Name: KADIAN
Applicant: WATSON LABS INC
Strength: 60MG
Application Number: N020616
Product Number: 005
Approval Date: Mar 9, 2001
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB1
Patent and Exclusivity Info for this product: View

Active Ingredient: MORPHINE SULFATE
Dosage Form;Route: CAPSULE, EXTENDED RELEASE;ORAL
Proprietary Name: KADIAN
Applicant: WATSON LABS INC
Strength: 80MG
Application Number: N020616
Product Number: 006
Approval Date: Oct 27, 2006
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB1
Patent and Exclusivity Info for this product: View

Active Ingredient: MORPHINE SULFATE
Dosage Form;Route: CAPSULE, EXTENDED RELEASE;ORAL
Proprietary Name: KADIAN
Applicant: WATSON LABS INC
Strength: 200MG
Application Number: N020616
Product Number: 007
Approval Date: Feb 27, 2007
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code: AB1
Patent and Exclusivity Info for this product: View

Active Ingredient: MORPHINE SULFATE
Dosage Form;Route: CAPSULE, EXTENDED RELEASE;ORAL
Proprietary Name: KADIAN
Applicant: WATSON LABS INC
Strength: 10MG
Application Number: N020616
Product Number: 008
Approval Date: Apr 20, 2007
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code: AB1
Patent and Exclusivity Info for this product: View

Active Ingredient: MORPHINE SULFATE
Dosage Form;Route: CAPSULE, EXTENDED RELEASE;ORAL
Proprietary Name: KADIAN
Applicant: WATSON LABS INC
Strength: 40MG
Application Number: N020616
Product Number: 009
Approval Date: Jul 9, 2012
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: MORPHINE SULFATE
Dosage Form;Route: CAPSULE, EXTENDED RELEASE;ORAL
Proprietary Name: KADIAN
Applicant: WATSON LABS INC
Strength: 70MG
Application Number: N020616
Product Number: 010
Approval Date: Jul 9, 2012
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: MORPHINE SULFATE
Dosage Form;Route: CAPSULE, EXTENDED RELEASE;ORAL
Proprietary Name: KADIAN
Applicant: WATSON LABS INC
Strength: 130MG
Application Number: N020616
Product Number: 011
Approval Date: Jul 9, 2012
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: MORPHINE SULFATE
Dosage Form;Route: CAPSULE, EXTENDED RELEASE;ORAL
Proprietary Name: KADIAN
Applicant: WATSON LABS INC
Strength: 150MG
Application Number: N020616
Product Number: 012
Approval Date: Jul 9, 2012
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

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FDA/Center for Drug Evaluation and Research
Office of Generic Drugs
Division of Labeling and Program Support
Update Frequency:

Orange Book Data - Monthly
Generic Drug Product Information & Patent Information - Daily
Orange Book Data Updated Through March 01, 2014
Patent and Generic Drug Product Data Last Updated April 18, 2014

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