FDA.reportPublic FDA data

Application 203068

Type
ANDA
Sponsor
AUROLIFE PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDETABLET;ORAL37.5MGNoNo

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
A203068-001PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203068-001AA

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 22:54:322026-06A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A203068-001AA1a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDEAurolife Pharma LLC5927e0f6-3de3-4885-a633-5b92003f6fe42026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203068
application number: ANDA203068
ndc (product): 13107-061
PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDEDIRECT RXc3dda0a4-b428-f3e7-e053-2995a90ad1062025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203068
application number: ANDA203068
ndc (product): 72189-203
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEProficient Rx LPb3c48b3c-fab7-4ea4-93b0-b108979e9da32022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203068
application number: ANDA203068
ndc (product): 63187-800

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
13107-061Phentermine HydrochloridePhentermine HydrochlorideAurolife Pharma, LLCANDACurrent
45865-556Phentermine HydrochloridePhentermine Hydrochloridemedsource pharmaceuticalsANDACurrent
50090-4216Phentermine HydrochloridePhentermine HydrochlorideA-S Medication SolutionsANDACurrent
50090-4216Phentermine HydrochloridePhentermine HydrochlorideA-S Medication SolutionsANDACurrent
50090-4216Phentermine HydrochloridePhentermine HydrochlorideA-S Medication SolutionsANDACurrent
52959-812Phentermine HydrochloridePhentermine HydrochlorideH.J. Harkins Company, Inc.ANDACurrent
63187-800Phentermine HydrochloridePhentermine HydrochlorideProficient Rx LPANDACurrent
63187-800Phentermine HydrochloridePhentermine HydrochlorideProficient Rx LPANDACurrent
63187-800Phentermine HydrochloridePhentermine HydrochlorideProficient Rx LPANDACurrent
63187-800Phentermine HydrochloridePhentermine HydrochlorideProficient Rx LPANDACurrent
63187-800Phentermine HydrochloridePhentermine HydrochlorideProficient Rx LPANDACurrent
70518-2278Phentermine HydrochloridePhentermine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2278Phentermine HydrochloridePhentermine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2278Phentermine HydrochloridePhentermine HydrochlorideREMEDYREPACK INC.ANDACurrent
72189-203PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDEDIRECT RXANDACurrent