Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 211542
Company: ALEMBIC PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TEMAZEPAM TEMAZEPAM 7.5MG CAPSULE;ORAL Prescription AB No No
TEMAZEPAM TEMAZEPAM 15MG CAPSULE;ORAL Prescription AB No No
TEMAZEPAM TEMAZEPAM 22.5MG CAPSULE;ORAL Prescription AB No No
TEMAZEPAM TEMAZEPAM 30MG 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
11/23/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

TEMAZEPAM

CAPSULE;ORAL; 7.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RESTORIL TEMAZEPAM 7.5MG CAPSULE;ORAL Prescription Yes AB 018163 SPECGX LLC
TEMAZEPAM TEMAZEPAM 7.5MG CAPSULE;ORAL Prescription No AB 211542 ALEMBIC PHARMS LTD
TEMAZEPAM TEMAZEPAM 7.5MG CAPSULE;ORAL Prescription No AB 203482 AMNEAL PHARMS
TEMAZEPAM TEMAZEPAM 7.5MG CAPSULE;ORAL Prescription No AB 070920 MYLAN
TEMAZEPAM TEMAZEPAM 7.5MG CAPSULE;ORAL Prescription No AB 071457 NOVEL LABS INC
TEMAZEPAM TEMAZEPAM 7.5MG CAPSULE;ORAL Prescription No AB 201781 PRINSTON INC
TEMAZEPAM TEMAZEPAM 7.5MG CAPSULE;ORAL Prescription No AB 078581 SUN PHARM INDUSTRIES

CAPSULE;ORAL; 15MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RESTORIL TEMAZEPAM 15MG CAPSULE;ORAL Prescription Yes AB 018163 SPECGX LLC
TEMAZEPAM TEMAZEPAM 15MG CAPSULE;ORAL Prescription No AB 071620 ACTAVIS ELIZABETH
TEMAZEPAM TEMAZEPAM 15MG CAPSULE;ORAL Prescription No AB 211542 ALEMBIC PHARMS LTD
TEMAZEPAM TEMAZEPAM 15MG CAPSULE;ORAL Prescription No AB 203482 AMNEAL PHARMS
TEMAZEPAM TEMAZEPAM 15MG CAPSULE;ORAL Prescription No AB 070920 MYLAN
TEMAZEPAM TEMAZEPAM 15MG CAPSULE;ORAL Prescription No AB 071456 NOVEL LABS INC
TEMAZEPAM TEMAZEPAM 15MG CAPSULE;ORAL Prescription No AB 201781 PRINSTON INC
TEMAZEPAM TEMAZEPAM 15MG CAPSULE;ORAL Prescription No AB 071427 SANDOZ

CAPSULE;ORAL; 22.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RESTORIL TEMAZEPAM 22.5MG CAPSULE;ORAL Prescription Yes AB 018163 SPECGX LLC
TEMAZEPAM TEMAZEPAM 22.5MG CAPSULE;ORAL Prescription No AB 211542 ALEMBIC PHARMS LTD
TEMAZEPAM TEMAZEPAM 22.5MG CAPSULE;ORAL Prescription No AB 203482 AMNEAL PHARMS
TEMAZEPAM TEMAZEPAM 22.5MG CAPSULE;ORAL Prescription No AB 070920 MYLAN
TEMAZEPAM TEMAZEPAM 22.5MG CAPSULE;ORAL Prescription No AB 071457 NOVEL LABS INC
TEMAZEPAM TEMAZEPAM 22.5MG CAPSULE;ORAL Prescription No AB 201781 PRINSTON INC
TEMAZEPAM TEMAZEPAM 22.5MG CAPSULE;ORAL Prescription No AB 071175 SUN PHARM INDUSTRIES

CAPSULE;ORAL; 30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RESTORIL TEMAZEPAM 30MG CAPSULE;ORAL Prescription Yes AB 018163 SPECGX LLC
TEMAZEPAM TEMAZEPAM 30MG CAPSULE;ORAL Prescription No AB 071620 ACTAVIS ELIZABETH
TEMAZEPAM TEMAZEPAM 30MG CAPSULE;ORAL Prescription No AB 211542 ALEMBIC PHARMS LTD
TEMAZEPAM TEMAZEPAM 30MG CAPSULE;ORAL Prescription No AB 203482 AMNEAL PHARMS
TEMAZEPAM TEMAZEPAM 30MG CAPSULE;ORAL Prescription No AB 070920 MYLAN
TEMAZEPAM TEMAZEPAM 30MG CAPSULE;ORAL Prescription No AB 071457 NOVEL LABS INC
TEMAZEPAM TEMAZEPAM 30MG CAPSULE;ORAL Prescription No AB 201781 PRINSTON INC
TEMAZEPAM TEMAZEPAM 30MG CAPSULE;ORAL Prescription No AB 071428 SANDOZ

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