Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208783
Company: NOVAST LABS
Company: NOVAST LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB3 | No | No |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB3 | No | No |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB3 | No | No |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB3 | No | No |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB3 | 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 |
---|---|---|---|---|---|---|---|
06/14/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
DILTIAZEM HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL; 120MG
TE Code = AB3
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CARDIZEM CD | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB3 | 020062 | BAUSCH |
CARTIA XT | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 074752 | ACTAVIS LABS FL INC |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 208783 | NOVAST LABS |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 074984 | PAR PHARM |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 203023 | SUN PHARM |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 205231 | TWI PHARMS |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 075116 | VALEANT PHARMS NORTH |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 206534 | ZYDUS PHARMS |
CAPSULE, EXTENDED RELEASE;ORAL; 180MG
TE Code = AB3
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CARDIZEM CD | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB3 | 020062 | BAUSCH |
CARTIA XT | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 074752 | ACTAVIS LABS FL INC |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 208783 | NOVAST LABS |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 074984 | PAR PHARM |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 203023 | SUN PHARM |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 205231 | TWI PHARMS |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 075116 | VALEANT PHARMS NORTH |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 206534 | ZYDUS PHARMS |
CAPSULE, EXTENDED RELEASE;ORAL; 240MG
TE Code = AB3
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CARDIZEM CD | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB3 | 020062 | BAUSCH |
CARTIA XT | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 074752 | ACTAVIS LABS FL INC |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 208783 | NOVAST LABS |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 074984 | PAR PHARM |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 203023 | SUN PHARM |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 205231 | TWI PHARMS |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 075116 | VALEANT PHARMS NORTH |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 206534 | ZYDUS PHARMS |
CAPSULE, EXTENDED RELEASE;ORAL; 300MG
TE Code = AB3
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CARDIZEM CD | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB3 | 020062 | BAUSCH |
CARTIA XT | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 074752 | ACTAVIS LABS FL INC |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 208783 | NOVAST LABS |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 074984 | PAR PHARM |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 203023 | SUN PHARM |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 205231 | TWI PHARMS |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 075116 | VALEANT PHARMS NORTH |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 206534 | ZYDUS PHARMS |
CAPSULE, EXTENDED RELEASE;ORAL; 360MG
TE Code = AB3
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CARDIZEM CD | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB3 | 020062 | BAUSCH |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 202463 | ACTAVIS ELIZABETH |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 208783 | NOVAST LABS |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 203023 | SUN PHARM |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 205231 | TWI PHARMS |
DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 206534 | ZYDUS PHARMS |