Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074910
Company: MYLAN
Company: MYLAN
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 | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
05/02/1997 | ORIG-1 | Approval |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/97/074910_diltiazem_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/12/2024 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
10/11/2002 | SUPPL-2 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
11/27/2000 | SUPPL-1 | Labeling |
Label is not available on this site. |
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 | 215775 | DR REDDYS LABS SA |
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 |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 217377 | TWI PHARMS |
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 | 215775 | DR REDDYS LABS SA |
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 |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 90MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 217377 | TWI PHARMS |
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 | 215775 | DR REDDYS LABS SA |
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 |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 217377 | TWI PHARMS |