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Product: Emerphed®(ephedrine sulfate) Injection
Company: Nexus Pharmaceuticals
Petition Filer: Nexus Pharmaceuticals
Petition Number(s): 2021P-0358
Date of Petition: April 8, 2021
Responding Petitions:Issue and Implication: Whether FDA regulations regarding restrictions on compounding pharmacies to make copies of FDA approved…Read more
Product: Ascor®(ascorbic acid) Injection
Company: McGuff Pharmaceuticals
Petition Filer: BPI Labs
Petition Number(s): 2021P-0345
Date of First Petition: April 1, 2021
Responding Petitions: NoneAction Requested of Petition: Petitioner would like to file an ANDA for an ascorbic acid injection 5000 mg/10 mL (500 mg/mL). Using the…Read more
Product: Indocin®(indomethacin) Suppositories
Company: Egalet US
Petition Filer: Zydus
Petition Number(s): 2021P-0344
Date of First Petition: April 1, 2021
Responding Petitions: NoneAction Requested of Petition: Petitioner would like to file an ANDA for an indomethacin suppository 100mg. Using the Indocin®(indomethacin) S…Read more
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Latest updates
Product: Emerphed®(ephedrine sulfate) Injection
Company: Nexus Pharmaceuticals
Petition Filer: Nexus Pharmaceuticals
Petition Number(s): 2021P-0358
Date of Petition: April 8, 2021
Responding Petitions:Issue and Implication: Whether FDA regulations regarding restrictions on compounding pharmacies to make copies of FDA approved…Read more
Product: Ascor®(ascorbic acid) Injection
Company: McGuff Pharmaceuticals
Petition Filer: BPI Labs
Petition Number(s): 2021P-0345
Date of First Petition: April 1, 2021
Responding Petitions: NoneAction Requested of Petition: Petitioner would like to file an ANDA for an ascorbic acid injection 5000 mg/10 mL (500 mg/mL). Using the…Read more
Product: Indocin®(indomethacin) Suppositories
Company: Egalet US
Petition Filer: Zydus
Petition Number(s): 2021P-0344
Date of First Petition: April 1, 2021
Responding Petitions: NoneAction Requested of Petition: Petitioner would like to file an ANDA for an indomethacin suppository 100mg. Using the Indocin®(indomethacin) S…Read more
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Latest updates
Product: Emerphed®(ephedrine sulfate) Injection
Company: Nexus Pharmaceuticals
Petition Filer: Nexus Pharmaceuticals
Petition Number(s): 2021P-0358
Date of Petition: April 8, 2021
Responding Petitions:Issue and Implication: Whether FDA regulations regarding restrictions on compounding pharmacies to make copies of FDA approved…Read more
Product: Ascor®(ascorbic acid) Injection
Company: McGuff Pharmaceuticals
Petition Filer: BPI Labs
Petition Number(s): 2021P-0345
Date of First Petition: April 1, 2021
Responding Petitions: NoneAction Requested of Petition: Petitioner would like to file an ANDA for an ascorbic acid injection 5000 mg/10 mL (500 mg/mL). Using the…Read more
Product: Indocin®(indomethacin) Suppositories
Company: Egalet US
Petition Filer: Zydus
Petition Number(s): 2021P-0344
Date of First Petition: April 1, 2021
Responding Petitions: NoneAction Requested of Petition: Petitioner would like to file an ANDA for an indomethacin suppository 100mg. Using the Indocin®(indomethacin) S…Read more
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Latest updates
Product: Emerphed®(ephedrine sulfate) Injection
Company: Nexus Pharmaceuticals
Petition Filer: Nexus Pharmaceuticals
Petition Number(s): 2021P-0358
Date of Petition: April 8, 2021
Responding Petitions:Issue and Implication: Whether FDA regulations regarding restrictions on compounding pharmacies to make copies of FDA approved…Read more
Product: Ascor®(ascorbic acid) Injection
Company: McGuff Pharmaceuticals
Petition Filer: BPI Labs
Petition Number(s): 2021P-0345
Date of First Petition: April 1, 2021
Responding Petitions: NoneAction Requested of Petition: Petitioner would like to file an ANDA for an ascorbic acid injection 5000 mg/10 mL (500 mg/mL). Using the…Read more
Product: Indocin®(indomethacin) Suppositories
Company: Egalet US
Petition Filer: Zydus
Petition Number(s): 2021P-0344
Date of First Petition: April 1, 2021
Responding Petitions: NoneAction Requested of Petition: Petitioner would like to file an ANDA for an indomethacin suppository 100mg. Using the Indocin®(indomethacin) S…Read more