Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 212317
Company: GLENMARK PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB1 No No
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 90MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB1 No No
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;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
03/22/2021 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212317Orig1s000ltr.pdf

DILTIAZEM HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL; 60MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB1 212317 GLENMARK PHARMS LTD
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB1 074910 MYLAN

CAPSULE, EXTENDED RELEASE;ORAL; 90MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 90MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB1 212317 GLENMARK PHARMS LTD
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 90MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB1 074910 MYLAN

CAPSULE, EXTENDED RELEASE;ORAL; 120MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB1 212317 GLENMARK PHARMS LTD
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB1 074910 MYLAN

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