Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216521
Company: SCIEGEN PHARMS INC
Company: SCIEGEN PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 30MG | TABLET;ORAL | Prescription | AB | No | No |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | AB | No | No |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 90MG | TABLET;ORAL | Prescription | AB | No | No |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 120MG | TABLET;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 |
---|---|---|---|---|---|---|---|
09/23/2022 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
DILTIAZEM HYDROCHLORIDE
TABLET;ORAL; 30MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CARDIZEM | DILTIAZEM HYDROCHLORIDE | 30MG | TABLET;ORAL | Prescription | Yes | AB | 018602 | BAUSCH |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 30MG | TABLET;ORAL | Prescription | No | AB | 216521 | SCIEGEN PHARMS INC |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 30MG | TABLET;ORAL | Prescription | No | AB | 074185 | TEVA |
TABLET;ORAL; 60MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CARDIZEM | DILTIAZEM HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | Yes | AB | 018602 | BAUSCH |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 216521 | SCIEGEN PHARMS INC |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 074185 | TEVA |
TABLET;ORAL; 90MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CARDIZEM | DILTIAZEM HYDROCHLORIDE | 90MG | TABLET;ORAL | Prescription | Yes | AB | 018602 | BAUSCH |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 90MG | TABLET;ORAL | Prescription | No | AB | 216521 | SCIEGEN PHARMS INC |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 90MG | TABLET;ORAL | Prescription | No | AB | 074185 | TEVA |
TABLET;ORAL; 120MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CARDIZEM | DILTIAZEM HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | Yes | AB | 018602 | BAUSCH |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | No | AB | 216521 | SCIEGEN PHARMS INC |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | No | AB | 074185 | TEVA |