Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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Search results from the "OB_Rx" table for query
on "020263."
| Active Ingredient: |
LEUPROLIDE ACETATE |
| Dosage Form;Route: |
INJECTABLE; INJECTION |
| Proprietary Name: |
LUPRON DEPOT-PED |
| Applicant: |
ABBOTT ENDOCRINE |
| Strength: |
7.5MG/VIAL |
| Application Number: |
N020263 |
| Product Number: |
002 |
| Approval Date: |
Apr 16, 1993 |
| Reference Listed Drug |
Yes |
| RX/OTC/DISCN: |
RX |
| TE Code: |
|
| Patent and Exclusivity Info for this product: |
View |
|
| Active Ingredient: |
LEUPROLIDE ACETATE |
| Dosage Form;Route: |
INJECTABLE; INJECTION |
| Proprietary Name: |
LUPRON DEPOT-PED |
| Applicant: |
ABBOTT ENDOCRINE |
| Strength: |
11.25MG/VIAL |
| Application Number: |
N020263 |
| Product Number: |
005 |
| Approval Date: |
Jan 21, 1994 |
| Reference Listed Drug |
Yes |
| RX/OTC/DISCN: |
RX |
| TE Code: |
|
| Patent and Exclusivity Info for this product: |
View |
|
| Active Ingredient: |
LEUPROLIDE ACETATE |
| Dosage Form;Route: |
INJECTABLE; INJECTION |
| Proprietary Name: |
LUPRON DEPOT-PED |
| Applicant: |
ABBOTT ENDOCRINE |
| Strength: |
15MG/VIAL |
| Application Number: |
N020263 |
| Product Number: |
006 |
| Approval Date: |
Jan 21, 1994 |
| Reference Listed Drug |
Yes |
| RX/OTC/DISCN: |
RX |
| TE Code: |
|
| Patent and Exclusivity Info for this product: |
View |
|
| Active Ingredient: |
LEUPROLIDE ACETATE |
| Dosage Form;Route: |
INJECTABLE; INJECTION |
| Proprietary Name: |
LUPRON DEPOT-PED |
| Applicant: |
ABBOTT ENDOCRINE |
| Strength: |
11.25MG/VIAL |
| Application Number: |
N020263 |
| Product Number: |
007 |
| Approval Date: |
Aug 15, 2011 |
| Reference Listed Drug |
Yes |
| RX/OTC/DISCN: |
RX |
| TE Code: |
|
| Patent and Exclusivity Info for this product: |
View |
|
| Active Ingredient: |
LEUPROLIDE ACETATE |
| Dosage Form;Route: |
INJECTABLE; INJECTION |
| Proprietary Name: |
LUPRON DEPOT-PED |
| Applicant: |
ABBOTT ENDOCRINE |
| Strength: |
30MG/VIAL |
| Application Number: |
N020263 |
| Product Number: |
008 |
| Approval Date: |
Aug 15, 2011 |
| Reference Listed Drug |
Yes |
| 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
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Office of Generic Drugs
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Division of Labeling and Program Support
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Update Frequency: |
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Orange Book Data - Monthly
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Generic Drug Product Information & Patent Information - Daily
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Orange Book Data Updated Through April, 2013
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Patent and Generic Drug Product Data Last Updated: May 17, 2013
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