Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 211033
Company: ALEMBIC PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLONAZEPAM CLONAZEPAM 0.125MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No
CLONAZEPAM CLONAZEPAM 0.25MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No
CLONAZEPAM CLONAZEPAM 0.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No
CLONAZEPAM CLONAZEPAM 1MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No
CLONAZEPAM CLONAZEPAM 2MG TABLET, ORALLY DISINTEGRATING;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
06/28/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

CLONAZEPAM

TABLET, ORALLY DISINTEGRATING;ORAL; 0.125MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLONAZEPAM CLONAZEPAM 0.125MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 211033 ALEMBIC PHARMS LTD
CLONAZEPAM CLONAZEPAM 0.125MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077194 BARR
CLONAZEPAM CLONAZEPAM 0.125MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077171 PAR PHARM
CLONAZEPAM CLONAZEPAM 0.125MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078654 SUN PHARM INDS INC

TABLET, ORALLY DISINTEGRATING;ORAL; 0.25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLONAZEPAM CLONAZEPAM 0.25MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 211033 ALEMBIC PHARMS LTD
CLONAZEPAM CLONAZEPAM 0.25MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077194 BARR
CLONAZEPAM CLONAZEPAM 0.25MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077171 PAR PHARM
CLONAZEPAM CLONAZEPAM 0.25MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078654 SUN PHARM INDS INC

TABLET, ORALLY DISINTEGRATING;ORAL; 0.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLONAZEPAM CLONAZEPAM 0.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 211033 ALEMBIC PHARMS LTD
CLONAZEPAM CLONAZEPAM 0.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077194 BARR
CLONAZEPAM CLONAZEPAM 0.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077171 PAR PHARM
CLONAZEPAM CLONAZEPAM 0.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078654 SUN PHARM INDS INC

TABLET, ORALLY DISINTEGRATING;ORAL; 1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLONAZEPAM CLONAZEPAM 1MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 211033 ALEMBIC PHARMS LTD
CLONAZEPAM CLONAZEPAM 1MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077194 BARR
CLONAZEPAM CLONAZEPAM 1MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077171 PAR PHARM
CLONAZEPAM CLONAZEPAM 1MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078654 SUN PHARM INDS INC

TABLET, ORALLY DISINTEGRATING;ORAL; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLONAZEPAM CLONAZEPAM 2MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 211033 ALEMBIC PHARMS LTD
CLONAZEPAM CLONAZEPAM 2MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077194 BARR
CLONAZEPAM CLONAZEPAM 2MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077171 PAR PHARM
CLONAZEPAM CLONAZEPAM 2MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078654 SUN PHARM INDS 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