Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210432
Company: RISING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREGABALIN PREGABALIN 25MG CAPSULE;ORAL Prescription AB No No
PREGABALIN PREGABALIN 50MG CAPSULE;ORAL Prescription AB No No
PREGABALIN PREGABALIN 75MG CAPSULE;ORAL Prescription AB No No
PREGABALIN PREGABALIN 100MG CAPSULE;ORAL Prescription AB No No
PREGABALIN PREGABALIN 150MG CAPSULE;ORAL Prescription AB No No
PREGABALIN PREGABALIN 200MG CAPSULE;ORAL Prescription AB No No
PREGABALIN PREGABALIN 225MG CAPSULE;ORAL Prescription AB No No
PREGABALIN PREGABALIN 300MG 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
07/19/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

PREGABALIN

CAPSULE;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LYRICA PREGABALIN 25MG CAPSULE;ORAL Prescription Yes AB 021446 PF PRISM CV
PREGABALIN PREGABALIN 25MG CAPSULE;ORAL Prescription No AB 203459 ALEMBIC PHARMS LTD
PREGABALIN PREGABALIN 25MG CAPSULE;ORAL Prescription No AB 211177 ALKEM LABS LTD
PREGABALIN PREGABALIN 25MG CAPSULE;ORAL Prescription No AB 209743 AMNEAL PHARMS CO
PREGABALIN PREGABALIN 25MG CAPSULE;ORAL Prescription No AB 209664 DR REDDYS
PREGABALIN PREGABALIN 25MG CAPSULE;ORAL Prescription No AB 206912 HETERO LABS LTD III
PREGABALIN PREGABALIN 25MG CAPSULE;ORAL Prescription No AB 211384 INVAGEN PHARMS
PREGABALIN PREGABALIN 25MG CAPSULE;ORAL Prescription No AB 209357 MSN LABS PVT LTD
PREGABALIN PREGABALIN 25MG CAPSULE;ORAL Prescription No AB 091228 MYLAN
PREGABALIN PREGABALIN 25MG CAPSULE;ORAL Prescription No AB 210432 RISING
PREGABALIN PREGABALIN 25MG CAPSULE;ORAL Prescription No AB 208677 SCIEGEN PHARMS INC
PREGABALIN PREGABALIN 25MG CAPSULE;ORAL Prescription No AB 091157 SUN PHARM
PREGABALIN PREGABALIN 25MG CAPSULE;ORAL Prescription No AB 091219 TEVA PHARMS

CAPSULE;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LYRICA PREGABALIN 50MG CAPSULE;ORAL Prescription Yes AB 021446 PF PRISM CV
PREGABALIN PREGABALIN 50MG CAPSULE;ORAL Prescription No AB 203459 ALEMBIC PHARMS LTD
PREGABALIN PREGABALIN 50MG CAPSULE;ORAL Prescription No AB 211177 ALKEM LABS LTD
PREGABALIN PREGABALIN 50MG CAPSULE;ORAL Prescription No AB 209743 AMNEAL PHARMS CO
PREGABALIN PREGABALIN 50MG CAPSULE;ORAL Prescription No AB 209664 DR REDDYS
PREGABALIN PREGABALIN 50MG CAPSULE;ORAL Prescription No AB 206912 HETERO LABS LTD III
PREGABALIN PREGABALIN 50MG CAPSULE;ORAL Prescription No AB 211384 INVAGEN PHARMS
PREGABALIN PREGABALIN 50MG CAPSULE;ORAL Prescription No AB 209357 MSN LABS PVT LTD
PREGABALIN PREGABALIN 50MG CAPSULE;ORAL Prescription No AB 091228 MYLAN
PREGABALIN PREGABALIN 50MG CAPSULE;ORAL Prescription No AB 210432 RISING
PREGABALIN PREGABALIN 50MG CAPSULE;ORAL Prescription No AB 208677 SCIEGEN PHARMS INC
PREGABALIN PREGABALIN 50MG CAPSULE;ORAL Prescription No AB 091157 SUN PHARM
PREGABALIN PREGABALIN 50MG CAPSULE;ORAL Prescription No AB 091219 TEVA PHARMS

CAPSULE;ORAL; 75MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LYRICA PREGABALIN 75MG CAPSULE;ORAL Prescription Yes AB 021446 PF PRISM CV
PREGABALIN PREGABALIN 75MG CAPSULE;ORAL Prescription No AB 203459 ALEMBIC PHARMS LTD
PREGABALIN PREGABALIN 75MG CAPSULE;ORAL Prescription No AB 207799 ALKEM LABS LTD
PREGABALIN PREGABALIN 75MG CAPSULE;ORAL Prescription No AB 209743 AMNEAL PHARMS CO
PREGABALIN PREGABALIN 75MG CAPSULE;ORAL Prescription No AB 209664 DR REDDYS
PREGABALIN PREGABALIN 75MG CAPSULE;ORAL Prescription No AB 206912 HETERO LABS LTD III
PREGABALIN PREGABALIN 75MG CAPSULE;ORAL Prescription No AB 211384 INVAGEN PHARMS
PREGABALIN PREGABALIN 75MG CAPSULE;ORAL Prescription No AB 209357 MSN LABS PVT LTD
PREGABALIN PREGABALIN 75MG CAPSULE;ORAL Prescription No AB 091228 MYLAN
PREGABALIN PREGABALIN 75MG CAPSULE;ORAL Prescription No AB 210432 RISING
PREGABALIN PREGABALIN 75MG CAPSULE;ORAL Prescription No AB 208677 SCIEGEN PHARMS INC
PREGABALIN PREGABALIN 75MG CAPSULE;ORAL Prescription No AB 210891 SHUANGCHENG
PREGABALIN PREGABALIN 75MG CAPSULE;ORAL Prescription No AB 091157 SUN PHARM
PREGABALIN PREGABALIN 75MG CAPSULE;ORAL Prescription No AB 091224 TEVA PHARMS

CAPSULE;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LYRICA PREGABALIN 100MG CAPSULE;ORAL Prescription Yes AB 021446 PF PRISM CV
PREGABALIN PREGABALIN 100MG CAPSULE;ORAL Prescription No AB 203459 ALEMBIC PHARMS LTD
PREGABALIN PREGABALIN 100MG CAPSULE;ORAL Prescription No AB 207799 ALKEM LABS LTD
PREGABALIN PREGABALIN 100MG CAPSULE;ORAL Prescription No AB 209743 AMNEAL PHARMS CO
PREGABALIN PREGABALIN 100MG CAPSULE;ORAL Prescription No AB 209664 DR REDDYS
PREGABALIN PREGABALIN 100MG CAPSULE;ORAL Prescription No AB 206912 HETERO LABS LTD III
PREGABALIN PREGABALIN 100MG CAPSULE;ORAL Prescription No AB 211384 INVAGEN PHARMS
PREGABALIN PREGABALIN 100MG CAPSULE;ORAL Prescription No AB 209357 MSN LABS PVT LTD
PREGABALIN PREGABALIN 100MG CAPSULE;ORAL Prescription No AB 091228 MYLAN
PREGABALIN PREGABALIN 100MG CAPSULE;ORAL Prescription No AB 210432 RISING
PREGABALIN PREGABALIN 100MG CAPSULE;ORAL Prescription No AB 208677 SCIEGEN PHARMS INC
PREGABALIN PREGABALIN 100MG CAPSULE;ORAL Prescription No AB 091157 SUN PHARM
PREGABALIN PREGABALIN 100MG CAPSULE;ORAL Prescription No AB 091224 TEVA PHARMS

CAPSULE;ORAL; 150MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LYRICA PREGABALIN 150MG CAPSULE;ORAL Prescription Yes AB 021446 PF PRISM CV
PREGABALIN PREGABALIN 150MG CAPSULE;ORAL Prescription No AB 203459 ALEMBIC PHARMS LTD
PREGABALIN PREGABALIN 150MG CAPSULE;ORAL Prescription No AB 207799 ALKEM LABS LTD
PREGABALIN PREGABALIN 150MG CAPSULE;ORAL Prescription No AB 209743 AMNEAL PHARMS CO
PREGABALIN PREGABALIN 150MG CAPSULE;ORAL Prescription No AB 209664 DR REDDYS
PREGABALIN PREGABALIN 150MG CAPSULE;ORAL Prescription No AB 206912 HETERO LABS LTD III
PREGABALIN PREGABALIN 150MG CAPSULE;ORAL Prescription No AB 211384 INVAGEN PHARMS
PREGABALIN PREGABALIN 150MG CAPSULE;ORAL Prescription No AB 209357 MSN LABS PVT LTD
PREGABALIN PREGABALIN 150MG CAPSULE;ORAL Prescription No AB 091228 MYLAN
PREGABALIN PREGABALIN 150MG CAPSULE;ORAL Prescription No AB 210432 RISING
PREGABALIN PREGABALIN 150MG CAPSULE;ORAL Prescription No AB 208677 SCIEGEN PHARMS INC
PREGABALIN PREGABALIN 150MG CAPSULE;ORAL Prescription No AB 091157 SUN PHARM
PREGABALIN PREGABALIN 150MG CAPSULE;ORAL Prescription No AB 091224 TEVA PHARMS

CAPSULE;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LYRICA PREGABALIN 200MG CAPSULE;ORAL Prescription Yes AB 021446 PF PRISM CV
PREGABALIN PREGABALIN 200MG CAPSULE;ORAL Prescription No AB 203459 ALEMBIC PHARMS LTD
PREGABALIN PREGABALIN 200MG CAPSULE;ORAL Prescription No AB 207799 ALKEM LABS LTD
PREGABALIN PREGABALIN 200MG CAPSULE;ORAL Prescription No AB 209743 AMNEAL PHARMS CO
PREGABALIN PREGABALIN 200MG CAPSULE;ORAL Prescription No AB 209664 DR REDDYS
PREGABALIN PREGABALIN 200MG CAPSULE;ORAL Prescription No AB 206912 HETERO LABS LTD III
PREGABALIN PREGABALIN 200MG CAPSULE;ORAL Prescription No AB 211384 INVAGEN PHARMS
PREGABALIN PREGABALIN 200MG CAPSULE;ORAL Prescription No AB 209357 MSN LABS PVT LTD
PREGABALIN PREGABALIN 200MG CAPSULE;ORAL Prescription No AB 091228 MYLAN
PREGABALIN PREGABALIN 200MG CAPSULE;ORAL Prescription No AB 210432 RISING
PREGABALIN PREGABALIN 200MG CAPSULE;ORAL Prescription No AB 208677 SCIEGEN PHARMS INC
PREGABALIN PREGABALIN 200MG CAPSULE;ORAL Prescription No AB 091157 SUN PHARM
PREGABALIN PREGABALIN 200MG CAPSULE;ORAL Prescription No AB 091224 TEVA PHARMS

CAPSULE;ORAL; 225MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LYRICA PREGABALIN 225MG CAPSULE;ORAL Prescription Yes AB 021446 PF PRISM CV
PREGABALIN PREGABALIN 225MG CAPSULE;ORAL Prescription No AB 203459 ALEMBIC PHARMS LTD
PREGABALIN PREGABALIN 225MG CAPSULE;ORAL Prescription No AB 207799 ALKEM LABS LTD
PREGABALIN PREGABALIN 225MG CAPSULE;ORAL Prescription No AB 209743 AMNEAL PHARMS CO
PREGABALIN PREGABALIN 225MG CAPSULE;ORAL Prescription No AB 209664 DR REDDYS
PREGABALIN PREGABALIN 225MG CAPSULE;ORAL Prescription No AB 206912 HETERO LABS LTD III
PREGABALIN PREGABALIN 225MG CAPSULE;ORAL Prescription No AB 211384 INVAGEN PHARMS
PREGABALIN PREGABALIN 225MG CAPSULE;ORAL Prescription No AB 209357 MSN LABS PVT LTD
PREGABALIN PREGABALIN 225MG CAPSULE;ORAL Prescription No AB 091228 MYLAN
PREGABALIN PREGABALIN 225MG CAPSULE;ORAL Prescription No AB 210432 RISING
PREGABALIN PREGABALIN 225MG CAPSULE;ORAL Prescription No AB 208677 SCIEGEN PHARMS INC
PREGABALIN PREGABALIN 225MG CAPSULE;ORAL Prescription No AB 091157 SUN PHARM
PREGABALIN PREGABALIN 225MG CAPSULE;ORAL Prescription No AB 091224 TEVA PHARMS

CAPSULE;ORAL; 300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LYRICA PREGABALIN 300MG CAPSULE;ORAL Prescription Yes AB 021446 PF PRISM CV
PREGABALIN PREGABALIN 300MG CAPSULE;ORAL Prescription No AB 203459 ALEMBIC PHARMS LTD
PREGABALIN PREGABALIN 300MG CAPSULE;ORAL Prescription No AB 207799 ALKEM LABS LTD
PREGABALIN PREGABALIN 300MG CAPSULE;ORAL Prescription No AB 209743 AMNEAL PHARMS CO
PREGABALIN PREGABALIN 300MG CAPSULE;ORAL Prescription No AB 209664 DR REDDYS
PREGABALIN PREGABALIN 300MG CAPSULE;ORAL Prescription No AB 206912 HETERO LABS LTD III
PREGABALIN PREGABALIN 300MG CAPSULE;ORAL Prescription No AB 211384 INVAGEN PHARMS
PREGABALIN PREGABALIN 300MG CAPSULE;ORAL Prescription No AB 209357 MSN LABS PVT LTD
PREGABALIN PREGABALIN 300MG CAPSULE;ORAL Prescription No AB 091228 MYLAN
PREGABALIN PREGABALIN 300MG CAPSULE;ORAL Prescription No AB 210432 RISING
PREGABALIN PREGABALIN 300MG CAPSULE;ORAL Prescription No AB 208677 SCIEGEN PHARMS INC
PREGABALIN PREGABALIN 300MG CAPSULE;ORAL Prescription No AB 210891 SHUANGCHENG
PREGABALIN PREGABALIN 300MG CAPSULE;ORAL Prescription No AB 091157 SUN PHARM
PREGABALIN PREGABALIN 300MG CAPSULE;ORAL Prescription No AB 091224 TEVA PHARMS

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