GDUFA
DMF Review : Reviewed
Rev. Date : 2025-07-21
Pay. Date : 2024-04-23
DMF Number : 39087
Submission : 2023-11-30
Status : Active
Type : II

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40985
Submission : 2024-12-25
Status : Active
Type : II

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FINISHED DOSAGE FORMULATIONS
Drug : MUPIROCIN
Dosage Form : OINTMENT; TOPICAL
Application Number : 90480
Country : US
Patented : No

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EXCIPIENTS BY APPLICATIONS
Application : Parenteral
Excipient Details : Used as an essential aminoacid in cell culture media in upstream
Pharmacopoeia Ref : On Request
Technical Specs : Low bacteria endotoxins, low bioburden (TAMC/TYMC). Customised pa...
Ingredient(s) : L-Alanine
Application : Topical
Excipient Details : L-Alanine is used in topical semi-solid dosage forms such as creams, lotions, ointments, gels, etc.
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REF. STANDARDS & IMPURITIES