Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 204446
Company: ACP NIMBLE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOXYCYCLINE DOXYCYCLINE EQ 50MG BASE CAPSULE;ORAL Prescription AB No No
DOXYCYCLINE DOXYCYCLINE EQ 75MG BASE CAPSULE;ORAL Prescription AB No No
DOXYCYCLINE DOXYCYCLINE EQ 100MG BASE 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
05/28/2015 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204446Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/17/2016 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

08/17/2016 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

DOXYCYCLINE

CAPSULE;ORAL; EQ 50MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOXYCYCLINE DOXYCYCLINE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 204446 ACP NIMBLE
DOXYCYCLINE DOXYCYCLINE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 204234 LUPIN LTD
DOXYCYCLINE DOXYCYCLINE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 209396 MAYNE PHARMA INC
DOXYCYCLINE DOXYCYCLINE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 065055 PAR PHARM
DOXYCYCLINE DOXYCYCLINE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 065053 SUN PHARM INDS LTD
DOXYCYCLINE DOXYCYCLINE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 205115 ZYDUS PHARMS

CAPSULE;ORAL; EQ 75MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOXYCYCLINE DOXYCYCLINE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 204446 ACP NIMBLE
DOXYCYCLINE DOXYCYCLINE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 209165 ALEMBIC PHARMS LTD
DOXYCYCLINE DOXYCYCLINE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 204234 LUPIN LTD
DOXYCYCLINE DOXYCYCLINE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 209396 MAYNE PHARMA INC
DOXYCYCLINE DOXYCYCLINE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 065053 SUN PHARM INDS LTD
DOXYCYCLINE DOXYCYCLINE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 205115 ZYDUS PHARMS

CAPSULE;ORAL; EQ 100MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOXYCYCLINE DOXYCYCLINE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 204446 ACP NIMBLE
DOXYCYCLINE DOXYCYCLINE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 209165 ALEMBIC PHARMS LTD
DOXYCYCLINE DOXYCYCLINE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 204234 LUPIN LTD
DOXYCYCLINE DOXYCYCLINE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 209396 MAYNE PHARMA INC
DOXYCYCLINE DOXYCYCLINE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 065055 PAR PHARM
DOXYCYCLINE DOXYCYCLINE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 065053 SUN PHARM INDS LTD
DOXYCYCLINE DOXYCYCLINE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 205115 ZYDUS PHARMS

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