FDA.reportPublic FDA data

Application 091211

Type
ANDA
Sponsor
GLENMARK GENERICS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATOVAQUONE AND PROGUANIL HYDROCHLORIDEATOVAQUONE; PROGUANIL HYDROCHLORIDETABLET;ORAL250MG;100MGNoNo
002ATOVAQUONE AND PROGUANIL HYDROCHLORIDEATOVAQUONE; PROGUANIL HYDROCHLORIDETABLET;ORAL62.5MG;25MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDEATOVAQUONE; PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-12
A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDEATOVAQUONE; PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A091211-001AB
A091211-002AB

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 22:54:322026-06A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-12a50c72e98297…
2026-08-01 22:54:322026-06A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A091211-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A091211-002AB1a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atovaquone and Proguanil HydrochlorideATOVAQUONE AND PROGUANIL HYDROCHLORIDEBryant Ranch Prepacke4ff57f7-07af-4872-ac3a-c521e098ccfe2026-07-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091211
application number: ANDA091211
Atovaquone and Proguanil HydrochlorideATOVAQUONE AND PROGUANIL HYDROCHLORIDEBluePoint Laboratoriesad25ab65-42aa-48f6-b5ed-247f3685d5bf2026-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091211
application number: ANDA091211
ndc (product): 68001-245
Atovaquone and Proguanil Hydrochloride PediatricATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRICGlenmark Pharmaceuticals Inc.,USA4b80d087-eaa7-448f-967e-344de7f164362026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091211
application number: ANDA091211
ndc (product): 68462-402
ndc (product): 68462-404
Atovaquone and Proguanil HydrochlorideATOVAQUONE AND PROGUANIL HYDROCHLORIDEProficient Rx LPe74b00fc-8743-4e9d-8a83-aab8e531b3ba2024-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091211
application number: ANDA091211
ndc (product): 63187-879

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-909Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
33261-900Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
42254-150Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideRebel Distributors CorpANDACurrent
43063-393Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-393Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-393Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-393Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-393Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-1302Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideA-S Medication SolutionsANDACurrent
50090-1302Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideA-S Medication SolutionsANDACurrent
50090-1302Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideA-S Medication SolutionsANDACurrent
50090-1302Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideA-S Medication SolutionsANDACurrent
50090-1302Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideA-S Medication SolutionsANDACurrent
50090-1302Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideA-S Medication SolutionsANDACurrent
60760-498Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
60760-498Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
60760-498Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
63187-879Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideProficient Rx LPANDACurrent
63187-879Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideProficient Rx LPANDACurrent
63187-879Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideProficient Rx LPANDACurrent
63187-879Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideProficient Rx LPANDACurrent
68001-245Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideBluePoint LaboratoriesANDACurrent
68001-245Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideBluePoint LaboratoriesANDACurrent
68001-245Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideBluePoint LaboratoriesANDACurrent
68001-245Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideBluePoint LaboratoriesANDACurrent
68258-1104Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideDispensing Solutions, Inc.ANDACurrent
68462-402Atovaquone and Proguanil Hydrochloride PediatricAtovaquone and Proguanil Hydrochloride PediatricGlenmark Pharmaceuticals Inc.,USAANDACurrent
68462-402Atovaquone and Proguanil Hydrochloride PediatricAtovaquone and Proguanil Hydrochloride PediatricGlenmark Pharmaceuticals Inc.,USAANDACurrent
68462-402Atovaquone and Proguanil Hydrochloride PediatricAtovaquone and Proguanil Hydrochloride PediatricGlenmark Pharmaceuticals Inc.,USAANDACurrent
68462-402Atovaquone and Proguanil Hydrochloride PediatricAtovaquone and Proguanil Hydrochloride PediatricGlenmark Pharmaceuticals Inc.,USAANDACurrent
68462-402Atovaquone and Proguanil Hydrochloride PediatricAtovaquone and Proguanil Hydrochloride PediatricGlenmark Pharmaceuticals Inc.,USAANDACurrent
68462-404Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideGlenmark Pharmaceuticals Inc.,USAANDACurrent
68462-404Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideGlenmark Pharmaceuticals Inc.,USAANDACurrent
68462-404Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideGlenmark Pharmaceuticals Inc.,USAANDACurrent
68462-404Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideGlenmark Pharmaceuticals Inc.,USAANDACurrent
68462-404Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideGlenmark Pharmaceuticals Inc.,USAANDACurrent