Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 213786
Company: MEITHEAL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DAPTOMYCIN DAPTOMYCIN 350MG/VIAL POWDER;IV (INFUSION) Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/29/2021 ORIG-1 Approval STANDARD

Label is not available on this site.

DAPTOMYCIN

POWDER;IV (INFUSION); 350MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DAPTOMYCIN DAPTOMYCIN 350MG/VIAL POWDER;IV (INFUSION) Prescription No AP 212667 ACCORD HLTHCARE
DAPTOMYCIN DAPTOMYCIN 350MG/VIAL POWDER;IV (INFUSION) Prescription No AP 213425 BE PHARMS
DAPTOMYCIN DAPTOMYCIN 350MG/VIAL POWDER;IV (INFUSION) Prescription No AP 211403 DR REDDYS
DAPTOMYCIN DAPTOMYCIN 350MG/VIAL POWDER;IV (INFUSION) Prescription No AP 213786 MEITHEAL
DAPTOMYCIN DAPTOMYCIN 350MG/VIAL POWDER;IV (INFUSION) Prescription Yes AP 208385 SAGENT PHARMS INC

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English