FDA.reportPublic FDA data

Application 075712

Type
ANDA
Sponsor
TORRENT PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARBAMAZEPINECARBAMAZEPINETABLET, CHEWABLE;ORAL100MGNoNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075712-001CARBAMAZEPINECARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2001-07-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075712-001AB

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 22:54:322026-06A075712-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2001-07-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A075712-001AB1a50c72e98297…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CARBAMAZEPINECARBAMAZEPINETorrent Pharmaceuticals Limited97e6e175-75e8-437b-b457-ddb1ae4e857d2026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075712
application number: ANDA075712
ndc (product): 13668-271
CARBAMAZEPINECARBAMAZEPINEMajor Pharmaceuticals2a8c7366-ce89-47ce-8123-96f26812fca02026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075712
application number: ANDA075712
ndc (product): 0904-3854
CARBAMAZEPINECARBAMAZEPINECoupler LLC5461e739-0f18-b012-e063-6394a90a6b142026-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075712
application number: ANDA075712
CARBAMAZEPINECARBAMAZEPINEBryant Ranch Prepackc72a0668-7cd7-46a8-86d1-d3c17c4b900f2026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075712
application number: ANDA075712
CarbamazepineCARBAMAZEPINEAmerican Health Packagingf8444c23-a74f-4d44-867e-26554dbb882f2025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075712
application number: ANDA075712
ndc (product): 60687-479

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-3854CARBAMAZEPINECARBAMAZEPINEMajor PharmaceuticalsANDACurrent
0904-3854CARBAMAZEPINECARBAMAZEPINEMajor PharmaceuticalsANDACurrent
0904-3854CARBAMAZEPINECARBAMAZEPINEMajor PharmaceuticalsANDACurrent
0904-3854CARBAMAZEPINECARBAMAZEPINEMajor PharmaceuticalsANDACurrent
13668-271CARBAMAZEPINECARBAMAZEPINETorrent Pharmaceuticals LimitedANDACurrent
13668-271CARBAMAZEPINECARBAMAZEPINETorrent Pharmaceuticals LimitedANDACurrent
13668-271CARBAMAZEPINECARBAMAZEPINETorrent Pharmaceuticals LimitedANDACurrent
13668-271CARBAMAZEPINECARBAMAZEPINETorrent Pharmaceuticals LimitedANDACurrent
13668-271CARBAMAZEPINECARBAMAZEPINETorrent Pharmaceuticals LimitedANDACurrent
53808-0858CARBAMAZEPINECARBAMAZEPINEState of Florida DOH Central PharmacyANDACurrent
60687-479CarbamazepineCarbamazepineAmerican Health PackagingANDACurrent
60687-479CarbamazepineCarbamazepineAmerican Health PackagingANDACurrent
60687-479CarbamazepineCarbamazepineAmerican Health PackagingANDACurrent
63629-8255CARBAMAZEPINECARBAMAZEPINEBryant Ranch PrepackANDACurrent
63629-8255CARBAMAZEPINECARBAMAZEPINEBryant Ranch PrepackANDACurrent
63629-8255CARBAMAZEPINECARBAMAZEPINEBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
24155ORIG2008-02-01