01 1AM REGENT
02 1AMNEAL
03 6ANI PHARMS
04 2BIONPHARMA
05 1CHENGDU SHUODE
06 10CHIESI
07 2CIPLA
08 2EPIC PHARMA LLC
09 1EUGIA PHARMA
10 2GLENMARK PHARMS LTD
11 1HIKMA
12 3HIKMA INTL PHARMS
13 2INFORLIFE
14 1MICRO LABS
15 1NAVINTA LLC
16 2NORVIUM BIOSCIENCE
17 1RK PHARMA
18 2SENORES PHARMS
19 2SKG PHARMA
20 1SUN PHARM
21 1WOCKHARDT
01 3CAPSULE, EXTENDED RELEASE;ORAL
02 20CAPSULE;ORAL
03 12INJECTABLE;INJECTION
04 10INJECTABLE;INTRAVENOUS
01 16DISCN
02 29RX
01 3CARDENE
02 1CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER
03 1CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER
04 1CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER
05 1CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER
06 3CARDENE SR
07 29NICARDIPINE HYDROCHLORIDE
08 1NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE
09 1NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE
10 4NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
01 32No
02 13Yes
RLD : Yes
TE Code :
Brand Name : CARDENE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1988-12-21
Application Number : 19488
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : CARDENE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1988-12-21
Application Number : 19488
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : CARDENE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 25MG/10ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1992-01-30
Application Number : 19734
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 20MG/200ML (0.1MG/ML)
Approval Date : 2008-07-31
Application Number : 19734
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code : AP
Brand Name : CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 20MG/200ML (0.1MG/ML)
Approval Date : 2008-07-31
Application Number : 19734
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AP
RLD : Yes
TE Code : AP
Brand Name : CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 40MG/200ML (0.2MG/ML)
Approval Date : 2008-11-07
Application Number : 19734
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AP
RLD : Yes
TE Code :
Brand Name : CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 40MG/200ML (0.2MG/ML)
Approval Date : 2008-11-07
Application Number : 19734
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : CARDENE SR
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1992-02-21
Application Number : 20005
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : CARDENE SR
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1992-02-21
Application Number : 20005
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : CARDENE SR
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1992-02-21
Application Number : 20005
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
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