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Approved Drug Products containing MolPort-001-758-011 listed in the FDA Orange Book. Original Data : FDA Website

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01 1DR REDDYS LABS INC

02 1TARO

03 1BRECKENRIDGE PHARM

04 1ANDRX PHARM

05 1AUROBINDO PHARMA

06 1CHARTWELL

07 1CIPLA

08 1EMED MEDCL

09 1GEDEON RICHTER USA

10 1GLENMARK PHARMS LTD

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13 4KARO HLTHCARE

14 1MYLAN

15 1NATCO PHARMA

16 4NOVARTIS

17 1ORBION PHARMS

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

RLD : No

TE Code : AB

TERBINAFINE HYDROCHLORIDE

Brand Name : TERBINAFINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 250MG BASE

Approval Date : 2007-07-02

Application Number : 76390

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Dr Reddy Company Banner

02

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TERBINAFINE HYDROCHLORIDE

Brand Name : TERBINAFINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 250MG BASE

Approval Date : 2010-06-04

Application Number : 77714

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Breckenridge Pharmaceutical

03

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TERBINAFINE HYDROCHLORIDE

Brand Name : TERBINAFINE HYDROCHLORIDE

Dosage Form : CREAM;TOPICAL

Dosage Strength : 1%

Approval Date : 2007-07-02

Application Number : 77511

RX/OTC/DISCN : OTC

RLD : No

TE Code :

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04

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TERBINAFINE HYDROCHLORIDE

Brand Name : LAMISIL

Dosage Form : SOLUTION;TOPICAL

Dosage Strength : 1%

Approval Date : 1997-10-17

Application Number : 20749

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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05

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TERBINAFINE HYDROCHLORIDE

Brand Name : LAMISIL

Dosage Form : CREAM;TOPICAL

Dosage Strength : 1%

Approval Date : 1999-03-09

Application Number : 20980

RX/OTC/DISCN : OTC

RLD : Yes

TE Code :

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06

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TERBINAFINE HYDROCHLORIDE

Brand Name : LAMISIL AT

Dosage Form : SOLUTION;TOPICAL

Dosage Strength : 1%

Approval Date : 2000-03-17

Application Number : 21124

RX/OTC/DISCN : OTC

RLD : Yes

TE Code :

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07

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TERBINAFINE HYDROCHLORIDE

Brand Name : LAMISIL AT

Dosage Form : SPRAY;TOPICAL

Dosage Strength : 1%

Approval Date : 2000-03-17

Application Number : 21124

RX/OTC/DISCN : OTC

RLD : Yes

TE Code :

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08

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TERBINAFINE HYDROCHLORIDE

Brand Name : LAMISIL

Dosage Form : CREAM;TOPICAL

Dosage Strength : 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1992-12-30

Application Number : 20192

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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09

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TERBINAFINE HYDROCHLORIDE

Brand Name : LAMISIL

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1996-05-10

Application Number : 20539

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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10

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TERBINAFINE HYDROCHLORIDE

Brand Name : LAMISIL

Dosage Form : GRANULE;ORAL

Dosage Strength : EQ 125MG BASE/PACKET

Approval Date : 2007-09-28

Application Number : 22071

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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