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 43.

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.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-1284e616aacf4f…
2026-09-14 22:38:342026-08A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-0684e616aacf4f…
2026-08-18 06:07:402026-07A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-12caaa826d4ba7…
2026-08-18 06:07:402026-07A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-0674a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A091211-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A091211-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A091211-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A091211-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091211-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091211-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091211-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091211-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091211-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091211-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091211-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091211-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091211-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091211-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091211-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091211-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091211-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091211-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091211-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091211-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091211-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091211-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091211-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091211-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091211-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091211-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091211-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091211-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091211-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091211-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091211-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091211-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091211-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091211-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091211-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091211-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091211-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091211-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091211-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091211-002AB174a2ff9319b5…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atovaquone and Proguanil HydrochlorideATOVAQUONE AND PROGUANIL HYDROCHLORIDEBluePoint Laboratoriesad25ab65-42aa-48f6-b5ed-247f3685d5bf2026-09-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091211
application number: ANDA091211
ndc (product): 68001-245
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 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