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Product: Zebeta®(bisoprolol) Tablets
Company: Teva
Petition Filer: Hyman Phelps, a law firm
Petition Number(s): 2021P-0037
Date of Petition: January 11, 2021
Responding Petitions: NoneAction Requested of Petition: Petitioner would like to file an ANDA for two dosage strengths of Zebeta®(bisoprolol) Tablets, being the 2.5mg (…Read more
Product: Quelicin®(succinylcholine) Injection
Company: Hospira
Petition Filer: Baxter Healthcare
Petition Number(s): 2020P-2317
Date of Petition: December 22, 2020
Responding Petitions:Action Requested by Petitioner: Petitioner is requesting FDA to determine whether Quelicin®(succinylcholine) Injection (NDA 008845) (Quelicin P…Read more
Product: Razadyne®(galantamine) Tablets
Company: Janssen
Petition Filer: Alpha Cognitition
Petition Number(s): 2020P-2301
Date of Petition: December 16, 2020
Responding Petitions:Issue and Implication: Whether FDA can designate a second Reference Standard when the current RS is discontinued or unavailable on the market.
Action…Read more
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Latest updates
Product: Zebeta®(bisoprolol) Tablets
Company: Teva
Petition Filer: Hyman Phelps, a law firm
Petition Number(s): 2021P-0037
Date of Petition: January 11, 2021
Responding Petitions: NoneAction Requested of Petition: Petitioner would like to file an ANDA for two dosage strengths of Zebeta®(bisoprolol) Tablets, being the 2.5mg (…Read more
Product: Quelicin®(succinylcholine) Injection
Company: Hospira
Petition Filer: Baxter Healthcare
Petition Number(s): 2020P-2317
Date of Petition: December 22, 2020
Responding Petitions:Action Requested by Petitioner: Petitioner is requesting FDA to determine whether Quelicin®(succinylcholine) Injection (NDA 008845) (Quelicin P…Read more
Product: Razadyne®(galantamine) Tablets
Company: Janssen
Petition Filer: Alpha Cognitition
Petition Number(s): 2020P-2301
Date of Petition: December 16, 2020
Responding Petitions:Issue and Implication: Whether FDA can designate a second Reference Standard when the current RS is discontinued or unavailable on the market.
Action…Read more
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Latest updates
Product: Zebeta®(bisoprolol) Tablets
Company: Teva
Petition Filer: Hyman Phelps, a law firm
Petition Number(s): 2021P-0037
Date of Petition: January 11, 2021
Responding Petitions: NoneAction Requested of Petition: Petitioner would like to file an ANDA for two dosage strengths of Zebeta®(bisoprolol) Tablets, being the 2.5mg (…Read more
Product: Quelicin®(succinylcholine) Injection
Company: Hospira
Petition Filer: Baxter Healthcare
Petition Number(s): 2020P-2317
Date of Petition: December 22, 2020
Responding Petitions:Action Requested by Petitioner: Petitioner is requesting FDA to determine whether Quelicin®(succinylcholine) Injection (NDA 008845) (Quelicin P…Read more
Product: Razadyne®(galantamine) Tablets
Company: Janssen
Petition Filer: Alpha Cognitition
Petition Number(s): 2020P-2301
Date of Petition: December 16, 2020
Responding Petitions:Issue and Implication: Whether FDA can designate a second Reference Standard when the current RS is discontinued or unavailable on the market.
Action…Read more
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Latest updates
Product: Zebeta®(bisoprolol) Tablets
Company: Teva
Petition Filer: Hyman Phelps, a law firm
Petition Number(s): 2021P-0037
Date of Petition: January 11, 2021
Responding Petitions: NoneAction Requested of Petition: Petitioner would like to file an ANDA for two dosage strengths of Zebeta®(bisoprolol) Tablets, being the 2.5mg (…Read more
Product: Quelicin®(succinylcholine) Injection
Company: Hospira
Petition Filer: Baxter Healthcare
Petition Number(s): 2020P-2317
Date of Petition: December 22, 2020
Responding Petitions:Action Requested by Petitioner: Petitioner is requesting FDA to determine whether Quelicin®(succinylcholine) Injection (NDA 008845) (Quelicin P…Read more
Product: Razadyne®(galantamine) Tablets
Company: Janssen
Petition Filer: Alpha Cognitition
Petition Number(s): 2020P-2301
Date of Petition: December 16, 2020
Responding Petitions:Issue and Implication: Whether FDA can designate a second Reference Standard when the current RS is discontinued or unavailable on the market.
Action…Read more