Application 091042

Type
ANDA
Sponsor
KVK TECH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATETABLET;ORAL35MGNoNo

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
A091042-001PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091042-001AA

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-313f01610625f2…
2019-09-15 20:21 UTC2019-09A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-31b00525d2431f…
2019-07-19 19:46 UTC2019-07A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-31cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A091042-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091042-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091042-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091042-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091042-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091042-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091042-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091042-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091042-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091042-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091042-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091042-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091042-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091042-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091042-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091042-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091042-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091042-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091042-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091042-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091042-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A091042-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091042-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091042-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091042-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A091042-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091042-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091042-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091042-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091042-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091042-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091042-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091042-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091042-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A091042-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A091042-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091042-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091042-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091042-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091042-001AA1cb3db0bc1861…

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phendimetrazine TartratePHENDIMETRAZINE TARTRATECalvin Scott & Co., Inc.f5c30a88-5814-5b42-e053-2995a90a437a2026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091042
application number: ANDA091042
Phendimetrazine TartratePHENDIMETRAZINE TARTRATEA-S Medication Solutionsef4cfd54-7d3e-4571-ae77-38ab2fd1af3d2026-01-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091042
application number: ANDA091042
ndc (product): 50090-2235
Phendimetrazine TartratePHENDIMETRAZINE TARTRATEPreferred Pharmaceuticals Inc.767b5386-1e56-4eeb-8d59-510b940ab75e2025-09-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091042
application number: ANDA091042
ndc (product): 68788-7236
Phendimetrazine TartratePHENDIMETRAZINE TARTRATENuCare Pharmaceuticals, Inc.342bc2a2-2751-b51a-e063-6394a90a4c432025-05-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091042
application number: ANDA091042
Phendimetrazine TartratePHENDIMETRAZINE TARTRATEA-S Medication Solutionsf1d265e1-522e-4a62-afda-29477fb94b8d2025-04-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091042
application number: ANDA091042
ndc (product): 50090-0715
Phendimetrazine TartratePHENDIMETRAZINE TARTRATEPD-Rx Pharmaceuticals, Inc.467ae7d7-e342-423b-be89-5d38c1abf3c92025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091042
application number: ANDA091042
ndc (product): 43063-510
Phendimetrazine TartratePHENDIMETRAZINE TARTRATEKVK-TECH, INC07bf3488-09e7-436f-af3f-94c35a7be0252024-12-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091042
application number: ANDA091042
ndc (product): 10702-078
ndc (product): 10702-077
ndc (product): 10702-045
Phendimetrazine TartratePHENDIMETRAZINE TARTRATENuCare Pharmaceuticals, Inc,40e5b0bf-347e-30f6-e054-00144ff88e882024-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091042
application number: ANDA091042
ndc (product): 66267-394
Phendimetrazine TartratePHENDIMETRAZINE TARTRATEBryant Ranch Prepack1c2370fd-6b40-48dc-a42d-2488041d5b372024-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091042
application number: ANDA091042
ndc (product): 71335-0324
ndc (product): 71335-0074
Phendimetrazine TartratePHENDIMETRAZINE TARTRATEA-S Medication Solutions7adaf128-fef4-4bbf-8b4a-875fe46bf68a2023-07-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091042
application number: ANDA091042

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 47 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-041Phendimetrazine TartratePhendimetrazine TartrateBlenheim Pharmacal, Inc.ANDACurrent
10702-045Phendimetrazine TartratePhendimetrazine TartrateKVK-TECH, INCANDACurrent
10702-045Phendimetrazine TartratePhendimetrazine TartrateKVK-TECH, INCANDACurrent
10702-077Phendimetrazine TartratePhendimetrazine TartrateKVK-TECH, INCANDACurrent
10702-077Phendimetrazine TartratePhendimetrazine TartrateKVK-TECH, INCANDACurrent
10702-078Phendimetrazine TartratePhendimetrazine TartrateKVK-TECH, INCANDACurrent
10702-078Phendimetrazine TartratePhendimetrazine TartrateKVK-TECH, INCANDACurrent
17224-500Phendimetrazine TartratePhendimetrazine TartrateCALVIN, SCOTT AND COMPANY, INCORPORATEDANDACurrent
17224-500Phendimetrazine TartratePhendimetrazine TartrateCALVIN, SCOTT AND COMPANY, INCORPORATEDANDACurrent
33261-341Phendimetrazine TartratePhendimetrazine TartrateAidarex Pharmaceuticals LLCANDACurrent
43063-510Phendimetrazine TartratePhendimetrazine TartratePD-Rx Pharmaceuticals, InANDACurrent
43063-510Phendimetrazine TartratePhendimetrazine TartratePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-510Phendimetrazine TartratePhendimetrazine TartratePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-510Phendimetrazine TartratePhendimetrazine TartratePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-510Phendimetrazine TartratePhendimetrazine TartratePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-510Phendimetrazine TartratePhendimetrazine TartratePD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-0715Phendimetrazine TartratePhendimetrazine TartrateA-S Medication SolutionsANDACurrent
50090-0715Phendimetrazine TartratePhendimetrazine TartrateA-S Medication SolutionsANDACurrent
50090-0715Phendimetrazine TartratePhendimetrazine TartrateA-S Medication SolutionsANDACurrent
50090-2235Phendimetrazine TartratePhendimetrazine TartrateA-S Medication SolutionsANDACurrent
50090-2235Phendimetrazine TartratePhendimetrazine TartrateA-S Medication SolutionsANDACurrent
50090-2235Phendimetrazine TartratePhendimetrazine TartrateA-S Medication SolutionsANDACurrent
50090-3976Phendimetrazine TartratePhendimetrazine TartrateA-S Medication SolutionsANDACurrent
50090-3976Phendimetrazine TartratePhendimetrazine TartrateA-S Medication SolutionsANDACurrent
51655-005PhendimetrazinePhendimetrazineNorthwind PharmaceuticalsANDACurrent
51655-005PhendimetrazinePhendimetrazineNorthwind PharmaceuticalsANDACurrent
51655-005PhendimetrazinePhendimetrazineNorthwind PharmaceuticalsANDACurrent
52959-282Phendimetrazine TartratePhendimetrazine TartrateH.J. Harkins Company, Inc.ANDACurrent
61502-922PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATEEPM Packaging IncANDACurrent
66267-394Phendimetrazine TartratePhendimetrazine TartrateNuCare Pharmaceuticals, Inc,ANDACurrent
66267-394Phendimetrazine TartratePhendimetrazine TartrateNuCare Pharmaceuticals, Inc,ANDACurrent
66267-394Phendimetrazine TartratePhendimetrazine TartrateNuCare Pharmaceuticals, Inc,ANDACurrent
68788-7236Phendimetrazine TartratePhendimetrazine TartratePreferred Pharmaceuticals Inc.ANDACurrent
68788-7236Phendimetrazine TartratePhendimetrazine TartratePreferred Pharmaceuticals Inc.ANDACurrent
68788-7236Phendimetrazine TartratePhendimetrazine TartratePreferred Pharmaceuticals Inc.ANDACurrent
68788-7236Phendimetrazine TartratePhendimetrazine TartratePreferred Pharmaceuticals Inc.ANDACurrent
68788-7236Phendimetrazine TartratePhendimetrazine TartratePreferred Pharmaceuticals Inc.ANDACurrent
70518-1430Phendimetrazine TartratePhendimetrazine TartrateREMEDYREPACK INC.ANDACurrent
70518-1430Phendimetrazine TartratePhendimetrazine TartrateREMEDYREPACK INC.ANDACurrent
71335-0074Phendimetrazine TartratePhendimetrazine TartrateBryant Ranch PrepackANDACurrent
71335-0074Phendimetrazine TartratePhendimetrazine TartrateBryant Ranch PrepackANDACurrent
71335-0074Phendimetrazine TartratePhendimetrazine TartrateBryant Ranch PrepackANDACurrent
71335-0324Phendimetrazine TartratePhendimetrazine TartrateBryant Ranch PrepackANDACurrent
71335-0324Phendimetrazine TartratePhendimetrazine TartrateBryant Ranch PrepackANDACurrent
71335-0324Phendimetrazine TartratePhendimetrazine TartrateBryant Ranch PrepackANDACurrent
71335-2135Phendimetrazine TartratePhendimetrazine TartrateBryant Ranch PrepackANDACurrent
75921-045Phendimetrazine TartratePhendimetrazine TartrateLife Line Home Care Services, Inc.ANDACurrent