Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 209908
Company: HETERO LABS LTD III
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TADALAFIL TADALAFIL 2.5MG TABLET;ORAL Prescription AB No No
TADALAFIL TADALAFIL 5MG TABLET;ORAL Prescription AB No No
TADALAFIL TADALAFIL 10MG TABLET;ORAL Prescription AB No No
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription AB1 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
03/26/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

TADALAFIL

TABLET;ORAL; 2.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CIALIS TADALAFIL 2.5MG TABLET;ORAL Prescription Yes AB 021368 LILLY
TADALAFIL TADALAFIL 2.5MG TABLET;ORAL Prescription No AB 209167 ACCORD HLTHCARE
TADALAFIL TADALAFIL 2.5MG TABLET;ORAL Prescription No AB 209654 AJANTA PHARMA LTD
TADALAFIL TADALAFIL 2.5MG TABLET;ORAL Prescription No AB 204809 ALEMBIC PHARMS LTD
TADALAFIL TADALAFIL 2.5MG TABLET;ORAL Prescription No AB 209744 AMNEAL PHARMS CO
TADALAFIL TADALAFIL 2.5MG TABLET;ORAL Prescription No AB 206285 AUROBINDO PHARMA LTD
TADALAFIL TADALAFIL 2.5MG TABLET;ORAL Prescription No AB 209539 CIPLA
TADALAFIL TADALAFIL 2.5MG TABLET;ORAL Prescription No AB 210069 DR REDDYS LABS LTD
TADALAFIL TADALAFIL 2.5MG TABLET;ORAL Prescription No AB 209908 HETERO LABS LTD III
TADALAFIL TADALAFIL 2.5MG TABLET;ORAL Prescription No AB 210567 LUPIN LTD
TADALAFIL TADALAFIL 2.5MG TABLET;ORAL Prescription No AB 207244 MACLEODS PHARMS LTD
TADALAFIL TADALAFIL 2.5MG TABLET;ORAL Prescription No AB 206956 MYLAN
TADALAFIL TADALAFIL 2.5MG TABLET;ORAL Prescription No AB 210420 QILU PHARM CO LTD
TADALAFIL TADALAFIL 2.5MG TABLET;ORAL Prescription No AB 208934 SUN PHARM
TADALAFIL TADALAFIL 2.5MG TABLET;ORAL Prescription No AB 211335 SUNSHINE LAKE
TADALAFIL TADALAFIL 2.5MG TABLET;ORAL Prescription No AB 090141 TEVA PHARMS USA
TADALAFIL TADALAFIL 2.5MG TABLET;ORAL Prescription No AB 211839 TORRENT
TADALAFIL TADALAFIL 2.5MG TABLET;ORAL Prescription No AB 209250 UNICHEM LABS LTD
TADALAFIL TADALAFIL 2.5MG TABLET;ORAL Prescription No AB 206693 ZYDUS PHARMS

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CIALIS TADALAFIL 5MG TABLET;ORAL Prescription Yes AB 021368 LILLY
TADALAFIL TADALAFIL 5MG TABLET;ORAL Prescription No AB 209167 ACCORD HLTHCARE
TADALAFIL TADALAFIL 5MG TABLET;ORAL Prescription No AB 209654 AJANTA PHARMA LTD
TADALAFIL TADALAFIL 5MG TABLET;ORAL Prescription No AB 204809 ALEMBIC PHARMS LTD
TADALAFIL TADALAFIL 5MG TABLET;ORAL Prescription No AB 209744 AMNEAL PHARMS CO
TADALAFIL TADALAFIL 5MG TABLET;ORAL Prescription No AB 206285 AUROBINDO PHARMA LTD
TADALAFIL TADALAFIL 5MG TABLET;ORAL Prescription No AB 209539 CIPLA
TADALAFIL TADALAFIL 5MG TABLET;ORAL Prescription No AB 210069 DR REDDYS LABS LTD
TADALAFIL TADALAFIL 5MG TABLET;ORAL Prescription No AB 209908 HETERO LABS LTD III
TADALAFIL TADALAFIL 5MG TABLET;ORAL Prescription No AB 210567 LUPIN LTD
TADALAFIL TADALAFIL 5MG TABLET;ORAL Prescription No AB 207244 MACLEODS PHARMS LTD
TADALAFIL TADALAFIL 5MG TABLET;ORAL Prescription No AB 206957 MYLAN
TADALAFIL TADALAFIL 5MG TABLET;ORAL Prescription No AB 210420 QILU PHARM CO LTD
TADALAFIL TADALAFIL 5MG TABLET;ORAL Prescription No AB 208934 SUN PHARM
TADALAFIL TADALAFIL 5MG TABLET;ORAL Prescription No AB 211335 SUNSHINE LAKE
TADALAFIL TADALAFIL 5MG TABLET;ORAL Prescription No AB 090141 TEVA PHARMS USA
TADALAFIL TADALAFIL 5MG TABLET;ORAL Prescription No AB 211839 TORRENT
TADALAFIL TADALAFIL 5MG TABLET;ORAL Prescription No AB 209250 UNICHEM LABS LTD
TADALAFIL TADALAFIL 5MG TABLET;ORAL Prescription No AB 206693 ZYDUS PHARMS

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CIALIS TADALAFIL 10MG TABLET;ORAL Prescription Yes AB 021368 LILLY
TADALAFIL TADALAFIL 10MG TABLET;ORAL Prescription No AB 209654 AJANTA PHARMA LTD
TADALAFIL TADALAFIL 10MG TABLET;ORAL Prescription No AB 204809 ALEMBIC PHARMS LTD
TADALAFIL TADALAFIL 10MG TABLET;ORAL Prescription No AB 209744 AMNEAL PHARMS CO
TADALAFIL TADALAFIL 10MG TABLET;ORAL Prescription No AB 206285 AUROBINDO PHARMA LTD
TADALAFIL TADALAFIL 10MG TABLET;ORAL Prescription No AB 209539 CIPLA
TADALAFIL TADALAFIL 10MG TABLET;ORAL Prescription No AB 210069 DR REDDYS LABS LTD
TADALAFIL TADALAFIL 10MG TABLET;ORAL Prescription No AB 209908 HETERO LABS LTD III
TADALAFIL TADALAFIL 10MG TABLET;ORAL Prescription No AB 210567 LUPIN LTD
TADALAFIL TADALAFIL 10MG TABLET;ORAL Prescription No AB 207244 MACLEODS PHARMS LTD
TADALAFIL TADALAFIL 10MG TABLET;ORAL Prescription No AB 206956 MYLAN
TADALAFIL TADALAFIL 10MG TABLET;ORAL Prescription No AB 210420 QILU PHARM CO LTD
TADALAFIL TADALAFIL 10MG TABLET;ORAL Prescription No AB 208934 SUN PHARM
TADALAFIL TADALAFIL 10MG TABLET;ORAL Prescription No AB 211335 SUNSHINE LAKE
TADALAFIL TADALAFIL 10MG TABLET;ORAL Prescription No AB 090141 TEVA PHARMS USA
TADALAFIL TADALAFIL 10MG TABLET;ORAL Prescription No AB 211839 TORRENT
TADALAFIL TADALAFIL 10MG TABLET;ORAL Prescription No AB 209250 UNICHEM LABS LTD
TADALAFIL TADALAFIL 10MG TABLET;ORAL Prescription No AB 206693 ZYDUS PHARMS

TABLET;ORAL; 20MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CIALIS TADALAFIL 20MG TABLET;ORAL Prescription Yes AB1 021368 LILLY
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB1 209167 ACCORD HLTHCARE
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB1 209654 AJANTA PHARMA LTD
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB1 204809 ALEMBIC PHARMS LTD
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB1 209744 AMNEAL PHARMS CO
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB1 206285 AUROBINDO PHARMA LTD
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB1 209539 CIPLA
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB1 210069 DR REDDYS LABS LTD
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB1 209908 HETERO LABS LTD III
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB1 210567 LUPIN LTD
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB1 207244 MACLEODS PHARMS LTD
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB1 206956 MYLAN
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB1 210420 QILU PHARM CO LTD
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB1 208934 SUN PHARM
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB1 211335 SUNSHINE LAKE
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB1 090141 TEVA PHARMS USA
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB1 211839 TORRENT
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB1 209250 UNICHEM LABS LTD
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB1 206693 ZYDUS PHARMS

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