FDA.reportPublic FDA data

Application 208175

Type
ANDA
Sponsor
DR REDDYS LABS SA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHENTERMINE HYDROCHLORIDE AND TOPIRAMATEPHENTERMINE HYDROCHLORIDE; TOPIRAMATECAPSULE, EXTENDED RELEASE;ORALEQ 3.75MG BASE;23MGNoNo
002PHENTERMINE HYDROCHLORIDE AND TOPIRAMATEPHENTERMINE HYDROCHLORIDE; TOPIRAMATECAPSULE, EXTENDED RELEASE;ORALEQ 7.5MG BASE;46MGNoNo
003PHENTERMINE HYDROCHLORIDE AND TOPIRAMATEPHENTERMINE HYDROCHLORIDE; TOPIRAMATECAPSULE, EXTENDED RELEASE;ORALEQ 11.25MG BASE;69MGNoNo
004PHENTERMINE HYDROCHLORIDE AND TOPIRAMATEPHENTERMINE HYDROCHLORIDE; TOPIRAMATECAPSULE, EXTENDED RELEASE;ORALEQ 15MG BASE;92MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208175-001PHENTERMINE HYDROCHLORIDE AND TOPIRAMATEPHENTERMINE HYDROCHLORIDE; TOPIRAMATEEQ 3.75MG BASE;23MGCAPSULE, EXTENDED RELEASE / ORALAB2025-06-12
A208175-002PHENTERMINE HYDROCHLORIDE AND TOPIRAMATEPHENTERMINE HYDROCHLORIDE; TOPIRAMATEEQ 7.5MG BASE;46MGCAPSULE, EXTENDED RELEASE / ORALAB2025-06-12
A208175-003PHENTERMINE HYDROCHLORIDE AND TOPIRAMATEPHENTERMINE HYDROCHLORIDE; TOPIRAMATEEQ 11.25MG BASE;69MGCAPSULE, EXTENDED RELEASE / ORALAB2025-06-12
A208175-004PHENTERMINE HYDROCHLORIDE AND TOPIRAMATEPHENTERMINE HYDROCHLORIDE; TOPIRAMATEEQ 15MG BASE;92MGCAPSULE, EXTENDED RELEASE / ORALAB2025-06-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A208175-001AB
A208175-002AB
A208175-003AB
A208175-004AB

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
2026-08-18 06:07:402026-07A208175-001PHENTERMINE HYDROCHLORIDE AND TOPIRAMATEEQ 3.75MG BASE;23MGCAPSULE, EXTENDED RELEASE / ORALAB2025-06-12caaa826d4ba7…
2026-08-18 06:07:402026-07A208175-002PHENTERMINE HYDROCHLORIDE AND TOPIRAMATEEQ 7.5MG BASE;46MGCAPSULE, EXTENDED RELEASE / ORALAB2025-06-12caaa826d4ba7…
2026-08-18 06:07:402026-07A208175-003PHENTERMINE HYDROCHLORIDE AND TOPIRAMATEEQ 11.25MG BASE;69MGCAPSULE, EXTENDED RELEASE / ORALAB2025-06-12caaa826d4ba7…
2026-08-18 06:07:402026-07A208175-004PHENTERMINE HYDROCHLORIDE AND TOPIRAMATEEQ 15MG BASE;92MGCAPSULE, EXTENDED RELEASE / ORALAB2025-06-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208175-001PHENTERMINE HYDROCHLORIDE AND TOPIRAMATEEQ 3.75MG BASE;23MGCAPSULE, EXTENDED RELEASE / ORALAB2025-06-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208175-002PHENTERMINE HYDROCHLORIDE AND TOPIRAMATEEQ 7.5MG BASE;46MGCAPSULE, EXTENDED RELEASE / ORALAB2025-06-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208175-003PHENTERMINE HYDROCHLORIDE AND TOPIRAMATEEQ 11.25MG BASE;69MGCAPSULE, EXTENDED RELEASE / ORALAB2025-06-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208175-004PHENTERMINE HYDROCHLORIDE AND TOPIRAMATEEQ 15MG BASE;92MGCAPSULE, EXTENDED RELEASE / ORALAB2025-06-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208175-001PHENTERMINE HYDROCHLORIDE AND TOPIRAMATEEQ 3.75MG BASE;23MGCAPSULE, EXTENDED RELEASE / ORALAB2025-06-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208175-002PHENTERMINE HYDROCHLORIDE AND TOPIRAMATEEQ 7.5MG BASE;46MGCAPSULE, EXTENDED RELEASE / ORALAB2025-06-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208175-003PHENTERMINE HYDROCHLORIDE AND TOPIRAMATEEQ 11.25MG BASE;69MGCAPSULE, EXTENDED RELEASE / ORALAB2025-06-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208175-004PHENTERMINE HYDROCHLORIDE AND TOPIRAMATEEQ 15MG BASE;92MGCAPSULE, EXTENDED RELEASE / ORALAB2025-06-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A208175-001PHENTERMINE HYDROCHLORIDE AND TOPIRAMATEEQ 3.75MG BASE;23MGCAPSULE, EXTENDED RELEASE / ORALAB2025-06-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208175-002PHENTERMINE HYDROCHLORIDE AND TOPIRAMATEEQ 7.5MG BASE;46MGCAPSULE, EXTENDED RELEASE / ORALAB2025-06-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208175-003PHENTERMINE HYDROCHLORIDE AND TOPIRAMATEEQ 11.25MG BASE;69MGCAPSULE, EXTENDED RELEASE / ORALAB2025-06-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208175-004PHENTERMINE HYDROCHLORIDE AND TOPIRAMATEEQ 15MG BASE;92MGCAPSULE, EXTENDED RELEASE / ORALAB2025-06-126a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208175-001PHENTERMINE HYDROCHLORIDE AND TOPIRAMATEEQ 3.75MG BASE;23MGCAPSULE, EXTENDED RELEASE / ORALAB2025-06-12a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208175-002PHENTERMINE HYDROCHLORIDE AND TOPIRAMATEEQ 7.5MG BASE;46MGCAPSULE, EXTENDED RELEASE / ORALAB2025-06-12a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208175-003PHENTERMINE HYDROCHLORIDE AND TOPIRAMATEEQ 11.25MG BASE;69MGCAPSULE, EXTENDED RELEASE / ORALAB2025-06-12a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208175-004PHENTERMINE HYDROCHLORIDE AND TOPIRAMATEEQ 15MG BASE;92MGCAPSULE, EXTENDED RELEASE / ORALAB2025-06-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A208175-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208175-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208175-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208175-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208175-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208175-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208175-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208175-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208175-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208175-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208175-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208175-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208175-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208175-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208175-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208175-004AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208175-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208175-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208175-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208175-004AB1a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phentermine and Topiramate Extended-ReleasePHENTERMINE AND TOPIRAMATE EXTENDED-RELEASEDr.Reddys Laboratories Inc260c3f90-163d-0bdd-1099-55d18a900e682026-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208175
application number: ANDA208175

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82578ORIG 2025-06-16