01 1AM REGENT
02 6ANI PHARMS
03 2BIONPHARMA
04 1CHENGDU SHUODE
05 10CHIESI
06 2CIPLA
07 2EPIC PHARMA LLC
08 1EUGIA PHARMA
09 2GLENMARK PHARMS LTD
10 3HIKMA INTL PHARMS
11 2INFORLIFE
12 1MICRO LABS
13 1NAVINTA LLC
14 2NORVIUM BIOSCIENCE
15 1RK PHARMA
16 2SENORES PHARMS
17 2SKG PHARMA
18 1SUN PHARM
19 1WEST-WARD PHARMS INT
20 1WOCKHARDT
01 3CAPSULE, EXTENDED RELEASE;ORAL
02 20CAPSULE;ORAL
03 11INJECTABLE;INJECTION
04 10INJECTABLE;INTRAVENOUS
01 16DISCN
02 28RX
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 28NICARDIPINE 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 31No
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Dosage Strength : 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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Dosage Strength : 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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Dosage Strength : 25MG/10ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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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