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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216631
Company: LUPIN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOXYCYCLINE DOXYCYCLINE 40MG CAPSULE;ORAL Prescription AB 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
04/08/2024 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216631Orig1s000ltr.pdf

DOXYCYCLINE

CAPSULE;ORAL; 40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOXYCYCLINE DOXYCYCLINE 40MG CAPSULE;ORAL Prescription No AB 217674 ALEMBIC
DOXYCYCLINE DOXYCYCLINE 40MG CAPSULE;ORAL Prescription No AB 217170 APOTEX
DOXYCYCLINE DOXYCYCLINE 40MG CAPSULE;ORAL Prescription No AB 218034 DR REDDYS
DOXYCYCLINE DOXYCYCLINE 40MG CAPSULE;ORAL Prescription No AB 216631 LUPIN
ORACEA DOXYCYCLINE 40MG CAPSULE;ORAL Prescription Yes AB 050805 GALDERMA LABS LP
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