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Approved Drug Products containing NCGC00024983-01 listed in the FDA Orange Book. Original Data : FDA Website

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01 1ACELLA

02 2ACTAVIS ELIZABETH

03 3ALEMBIC

04 3ALKEM LABS LTD

05 3AUROBINDO PHARMA

06 3AUROBINDO PHARMA USA

07 2BAYER PHARMS

08 2CHASE LABS NJ

09 1ELITE PHARM SOLUTION

10 3ENDO OPERATIONS

11 2HERITAGE PHARMA

12 2LEADING

13 2MARTEC USA LLC

14 1NORVIUM BIOSCIENCE

15 3NORWICH

16 6NOVAST LABS

17 3OSMOTICA PHARM US

18 5PFIZER

19 6RISING

20 3SPIL

21 2SWISS PHARM

22 1TEVA

23 3TWI PHARMS

24 5VALEANT PHARMS NORTH

25 1WATSON LABS

26 1WATSON LABS TEVA

27 6ZYDUS PHARMS

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PharmaCompass

01

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

NIFEDIPINE

Brand Name : ADALAT CC

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1993-04-21

Application Number : 20198

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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02

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

NIFEDIPINE

Brand Name : ADALAT CC

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1993-04-21

Application Number : 20198

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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03

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

NIFEDIPINE

Brand Name : ADALAT CC

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1993-04-21

Application Number : 20198

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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04

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

NIFEDIPINE

Brand Name : ADALAT

Dosage Form : CAPSULE;ORAL

Dosage Strength : 10MG

Approval Date : 1985-11-27

Application Number : 19478

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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05

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

NIFEDIPINE

Brand Name : ADALAT

Dosage Form : CAPSULE;ORAL

Dosage Strength : 20MG

Approval Date : 1986-09-17

Application Number : 19478

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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06

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

NIFEDIPINE

Brand Name : PROCARDIA

Dosage Form : CAPSULE;ORAL

Dosage Strength : 10MG

Approval Date : 1982-01-01

Application Number : 18482

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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07

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

NIFEDIPINE

Brand Name : PROCARDIA

Dosage Form : CAPSULE;ORAL

Dosage Strength : 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1986-07-24

Application Number : 18482

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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08

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

NIFEDIPINE

Brand Name : PROCARDIA XL

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 30MG

Approval Date : 1989-09-06

Application Number : 19684

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB2

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09

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

NIFEDIPINE

Brand Name : PROCARDIA XL

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 60MG

Approval Date : 1989-09-06

Application Number : 19684

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB2

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10

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

NIFEDIPINE

Brand Name : PROCARDIA XL

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 90MG

Approval Date : 1989-09-06

Application Number : 19684

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB2

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