FDA.reportPublic FDA data

Application 077802

Type
ANDA
Sponsor
GLENMARK PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXCARBAZEPINEOXCARBAZEPINETABLET;ORAL150MGNoNo
002OXCARBAZEPINEOXCARBAZEPINETABLET;ORAL300MGNoNo
003OXCARBAZEPINEOXCARBAZEPINETABLET;ORAL600MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077802-001OXCARBAZEPINEOXCARBAZEPINE150MGTABLET / ORALAB2007-10-09
A077802-002OXCARBAZEPINEOXCARBAZEPINE300MGTABLET / ORALAB2007-10-09
A077802-003OXCARBAZEPINEOXCARBAZEPINE600MGTABLET / ORALAB2007-10-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A077802-001AB
A077802-002AB
A077802-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A077802-001OXCARBAZEPINE150MGTABLET / ORALAB2007-10-09a50c72e98297…
2026-08-01 22:54:322026-06A077802-002OXCARBAZEPINE300MGTABLET / ORALAB2007-10-09a50c72e98297…
2026-08-01 22:54:322026-06A077802-003OXCARBAZEPINE600MGTABLET / ORALAB2007-10-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A077802-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A077802-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A077802-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OxcarbazepineOXCARBAZEPINECoupler LLC51008af2-39ac-546c-e063-6294a90a758f2026-05-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077802
application number: ANDA077802
OxcarbazepineOXCARBAZEPINECoupler LLC50873ef7-3deb-7386-e063-6394a90a9c192026-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077802
application number: ANDA077802
OxcarbazepineOXCARBAZEPINEREMEDYREPACK INC.a90cd1f1-5258-4b0e-92fd-c4cebe47772b2026-04-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077802
application number: ANDA077802
ndc (product): 70518-3197
OxcarbazepineOXCARBAZEPINEREMEDYREPACK INC.a2032bcc-2da5-45e5-aa3f-ddbf50909df82026-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077802
application number: ANDA077802
ndc (product): 70518-3237
OxcarbazepineOXCARBAZEPINEGlenmark Pharmaceuticals Inc., USA1c713b59-a628-42e6-b166-ae71c39132842025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077802
application number: ANDA077802
ndc (product): 68462-137
ndc (product): 68462-138
ndc (product): 68462-139
OxcarbazepineOXCARBAZEPINEDirect_rx21b0cc84-b64a-75de-e063-6294a90a9dd02024-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077802
application number: ANDA077802
OxcarbazepineOXCARBAZEPINEProficient Rx LP95867dcd-fd0e-4570-987b-d35939f7d7d12022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077802
application number: ANDA077802
ndc (product): 71205-411

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-862OxcarbazepineOxcarbazepineRebel Distributors CorpANDACurrent
21695-863OxcarbazepineOxcarbazepineRebel Distributors CorpANDACurrent
21695-864OxcarbazepineOxcarbazepineRebel Distributors CorpANDACurrent
50090-3961OxcarbazepineOxcarbazepineA-S Medication SolutionsANDACurrent
55700-569OxcarbazepineOxcarbazepineLake Erie Medical DBA Quality Care Products LLCANDACurrent
61919-569TRILEPTALOXCARBAZEPINEDIRECT RXANDACurrent
64725-0137OxcarbazepineOxcarbazepineTYA PharmaceuticalsANDACurrent
68462-137OxcarbazepineOxcarbazepineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-137OxcarbazepineOxcarbazepineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-137OxcarbazepineOxcarbazepineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-137OxcarbazepineOxcarbazepineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-138OxcarbazepineOxcarbazepineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-138OxcarbazepineOxcarbazepineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-138OxcarbazepineOxcarbazepineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-138OxcarbazepineOxcarbazepineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-139OxcarbazepineOxcarbazepineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-139OxcarbazepineOxcarbazepineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-139OxcarbazepineOxcarbazepineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-139OxcarbazepineOxcarbazepineGlenmark Pharmaceuticals Inc., USAANDACurrent
70518-3127OxcarbazepineOxcarbazepineREMEDYREPACK INC.ANDACurrent
70518-3127OxcarbazepineOxcarbazepineREMEDYREPACK INC.ANDACurrent
70518-3197OxcarbazepineOxcarbazepineREMEDYREPACK INC.ANDACurrent
70518-3197OxcarbazepineOxcarbazepineREMEDYREPACK INC.ANDACurrent
70518-3237OxcarbazepineOxcarbazepineREMEDYREPACK INC.ANDACurrent
71205-411OxcarbazepineOxcarbazepineProficient Rx LPANDACurrent
71205-411OxcarbazepineOxcarbazepineProficient Rx LPANDACurrent
71335-0144OxcarbazepineOxcarbazepineBryant Ranch PrepackANDACurrent
71335-0410OxcarbazepineOxcarbazepineBryant Ranch PrepackANDACurrent
71335-0978OxcarbazepineOxcarbazepineBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
24168ORIG2007-10-23
39542ORIG2007-10-10
9086ORIG2007-10-10