Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074928
Company: EPIC PHARMA LLC
Company: EPIC PHARMA LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | 20MG | CAPSULE;ORAL | Prescription | AB | No | No |
NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | 30MG | CAPSULE;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
03/19/1998 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74928ap_appltr_prntlbl_chemr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74928ap_appltr_prntlbl_chemr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74928.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/17/2002 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
12/15/1999 | SUPPL-4 | Labeling |
Label is not available on this site. |
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12/01/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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12/01/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/01/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/19/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74928ap_appltr_prntlbl_chemr.pdf |
NICARDIPINE HYDROCHLORIDE
CAPSULE;ORAL; 20MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 074670 | ANI PHARMS |
NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 217555 | BIONPHARMA |
NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 074928 | EPIC PHARMA LLC |
NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 216357 | GLENMARK PHARMS LTD |
NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 215377 | SENORES PHARMS |
NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 218202 | SKG PHARMA |
CAPSULE;ORAL; 30MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | 30MG | CAPSULE;ORAL | Prescription | No | AB | 074670 | ANI PHARMS |
NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | 30MG | CAPSULE;ORAL | Prescription | No | AB | 217555 | BIONPHARMA |
NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | 30MG | CAPSULE;ORAL | Prescription | No | AB | 074928 | EPIC PHARMA LLC |
NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | 30MG | CAPSULE;ORAL | Prescription | No | AB | 216357 | GLENMARK PHARMS LTD |
NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | 30MG | CAPSULE;ORAL | Prescription | No | AB | 215377 | SENORES PHARMS |
NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | 30MG | CAPSULE;ORAL | Prescription | No | AB | 218202 | SKG PHARMA |