Drugs@FDA: FDA-Approved Drugs
Company: TEVA
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 |
---|---|---|---|---|---|---|---|
05/31/1995 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/29/2020 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
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04/29/2020 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
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01/27/2011 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
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12/02/1999 | SUPPL-12 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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12/02/1999 | SUPPL-11 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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02/12/1999 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/12/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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01/08/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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06/06/1997 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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01/24/1997 | SUPPL-1 | Labeling |
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 |