Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 202383

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LAMOTRIGINE (LAMOTRIGINE)
25MG
Marketing Status: Prescription

Active Ingredient: LAMOTRIGINE
Proprietary Name: LAMOTRIGINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A202383
Product Number: 001
Approval Date: Jun 19, 2013
Applicant Holder Full Name: DR REDDYS LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

LAMOTRIGINE (LAMOTRIGINE)
50MG
Marketing Status: Prescription

Active Ingredient: LAMOTRIGINE
Proprietary Name: LAMOTRIGINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A202383
Product Number: 002
Approval Date: Jun 19, 2013
Applicant Holder Full Name: DR REDDYS LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

LAMOTRIGINE (LAMOTRIGINE)
100MG
Marketing Status: Prescription

Active Ingredient: LAMOTRIGINE
Proprietary Name: LAMOTRIGINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A202383
Product Number: 003
Approval Date: Jun 19, 2013
Applicant Holder Full Name: DR REDDYS LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

LAMOTRIGINE (LAMOTRIGINE)
200MG
Marketing Status: Prescription

Active Ingredient: LAMOTRIGINE
Proprietary Name: LAMOTRIGINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A202383
Product Number: 004
Approval Date: Jun 19, 2013
Applicant Holder Full Name: DR REDDYS LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

LAMOTRIGINE (LAMOTRIGINE)
250MG
Marketing Status: Prescription

Active Ingredient: LAMOTRIGINE
Proprietary Name: LAMOTRIGINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 250MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A202383
Product Number: 006
Approval Date: Sep 6, 2018
Applicant Holder Full Name: DR REDDYS LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

LAMOTRIGINE (LAMOTRIGINE)
300MG
Marketing Status: Prescription

Active Ingredient: LAMOTRIGINE
Proprietary Name: LAMOTRIGINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 300MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A202383
Product Number: 005
Approval Date: Jun 19, 2013
Applicant Holder Full Name: DR REDDYS LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information