Application 209312

Type
ANDA
Sponsor
GRANULES INDIA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHOCARBAMOLMETHOCARBAMOLTABLET;ORAL500MGNoYes
002METHOCARBAMOLMETHOCARBAMOLTABLET;ORAL750MGNoNo

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
A209312-001METHOCARBAMOLMETHOCARBAMOL500MGTABLET / ORALAARS2018-05-07
A209312-002METHOCARBAMOLMETHOCARBAMOL750MGTABLET / ORALAARS2018-05-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209312-001AA
A209312-002AA

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 22:38:342026-08A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-0784e616aacf4f…
2026-09-14 22:38:342026-08A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-0784e616aacf4f…
2026-08-18 06:07:402026-07A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-07caaa826d4ba7…
2026-08-18 06:07:402026-07A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-078072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-075c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-075d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-074b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-0774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A209312-002METHOCARBAMOL750MGTABLET / ORALAA2018-05-0774a2ff9319b5…

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 22:38:342026-08A209312-001AA184e616aacf4f…
2026-09-14 22:38:342026-08A209312-002AA184e616aacf4f…
2026-08-18 06:07:402026-07A209312-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A209312-002AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209312-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209312-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209312-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209312-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209312-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209312-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209312-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209312-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209312-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209312-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209312-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209312-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209312-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209312-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209312-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209312-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209312-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209312-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209312-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209312-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209312-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209312-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209312-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209312-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209312-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209312-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209312-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209312-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209312-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209312-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209312-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A209312-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209312-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A209312-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209312-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A209312-002AA174a2ff9319b5…

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 2 · 33 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethocarbamolMETHOCARBAMOL TABLETSCoupler LLC5a585c87-6361-420d-e063-6294a90a18382026-08-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSREMEDYREPACK INC.1dc3a5b1-c83b-406b-a59d-ce8075e4ccf92026-08-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSREMEDYREPACK INC.52b20439-6bf4-435e-817a-c3b3fc70846a2026-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
ndc (product): 70518-1723
MethocarbamolMETHOCARBAMOL TABLETSREMEDYREPACK INC.37767123-8b72-4e1f-b00d-ff3305e9923f2026-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
ndc (product): 70518-1738
MethocarbamolMETHOCARBAMOL TABLETSUnit Dose Solutions, Inc.561ae476-9e1f-038a-e063-6394a90aa5c72026-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSGranules Pharmaceuticals Inc.6f0d3966-962d-fa7c-e053-2a91aa0a8e3c2026-07-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSBryant Ranch Prepack65c460f6-6470-41ff-abb4-d9d54ecc52f72026-07-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
ndc (product): 71335-0909
MethocarbamolMETHOCARBAMOL TABLETSSt. Mary's Medical Park Pharmacy7d4dd78a-f902-6ff2-e053-2991aa0ac7d72026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSPreferred Pharmaceuticals Inc.43f83b87-e169-46fe-98bd-6af373595bd32026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSPreferred Pharmaceuticals Inc.e03878d3-d780-4e7f-b828-20ac2a1099332026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSCoupler LLC52b87514-e6e0-ab57-e063-6394a90a6b232026-05-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSNuCare Pharmaceuticals,Inc.71c21226-cd96-33ed-e053-2995a90a52692026-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSSt. Mary's Medical Park Pharmacyfaa81ad3-2bd2-d637-e053-6294a90a2d362026-05-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSProficient Rx LP23163bc1-dec7-41f6-baed-eedebfd6be7e2026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
ndc (product): 71205-167
MethocarbamolMETHOCARBAMOL TABLETSAdvanced Rx of Tennessee, LLC4de118fe-bd8e-6cc4-e063-6394a90a13202026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSAdvanced Rx of Tennessee, LLC4cefe51c-d824-a862-e063-6394a90a77172026-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSRedpharm Drug44f264fd-bf40-bed9-e063-6294a90ac44a2026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSNuCare Pharmaceuticals,Inc.72f36d28-15d2-30f6-e053-2a91aa0ad1ce2026-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSNorthwind Health Company, LLCf2b4ed95-0469-393a-e053-2a95a90a98ed2026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
METHOCARBAMOLMETHOCARBAMOLDIRECT RX31508051-c9cb-149b-e054-00144ff88e882026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 115 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70518-1723MethocarbamolMethocarbamol TabletsREMEDYREPACK INC.ANDACurrent
70518-1723MethocarbamolMethocarbamol TabletsREMEDYREPACK INC.ANDACurrent
70518-1723MethocarbamolMethocarbamol TabletsREMEDYREPACK INC.ANDACurrent
70518-1738MethocarbamolMethocarbamol TabletsREMEDYREPACK INC.ANDACurrent
70518-1738MethocarbamolMethocarbamol TabletsREMEDYREPACK INC.ANDACurrent
70518-1738MethocarbamolMethocarbamol TabletsREMEDYREPACK INC.ANDACurrent
70518-1738MethocarbamolMethocarbamol TabletsREMEDYREPACK INC.ANDACurrent
70518-1738MethocarbamolMethocarbamol TabletsREMEDYREPACK INC.ANDACurrent
70518-1738MethocarbamolMethocarbamol TabletsREMEDYREPACK INC.ANDACurrent
70518-1738MethocarbamolMethocarbamol TabletsREMEDYREPACK INC.ANDACurrent
70518-1738MethocarbamolMethocarbamol TabletsREMEDYREPACK INC.ANDACurrent
70518-1738MethocarbamolMethocarbamol TabletsREMEDYREPACK INC.ANDACurrent
70518-1738MethocarbamolMethocarbamol TabletsREMEDYREPACK INC.ANDACurrent
70934-146MethocarbamolMethocarbamol TabletsDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-146MethocarbamolMethocarbamol TabletsDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-146MethocarbamolMethocarbamol TabletsDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-756MethocarbamolMethocarbamol TabletsDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71205-068MethocarbamolMethocarbamol TabletsProficient Rx LPANDACurrent
71205-068MethocarbamolMethocarbamol TabletsProficient Rx LPANDACurrent
71205-068MethocarbamolMethocarbamol TabletsProficient Rx LPANDACurrent
71205-068MethocarbamolMethocarbamol TabletsProficient Rx LPANDACurrent
71205-167MethocarbamolMethocarbamol TabletsProficient Rx LPANDACurrent
71205-167MethocarbamolMethocarbamol TabletsProficient Rx LPANDACurrent
71205-167MethocarbamolMethocarbamol TabletsProficient Rx LPANDACurrent
71335-0909MethocarbamolMethocarbamol TabletsBryant Ranch PrepackANDACurrent
71335-0909MethocarbamolMethocarbamol TabletsBryant Ranch PrepackANDACurrent
71335-0909MethocarbamolMethocarbamol TabletsBryant Ranch PrepackANDACurrent
71335-0910MethocarbamolMethocarbamol TabletsBryant Ranch PrepackANDACurrent
71335-0910MethocarbamolMethocarbamol TabletsBryant Ranch PrepackANDACurrent
71335-0910MethocarbamolMethocarbamol TabletsBryant Ranch PrepackANDACurrent
71610-134MethocarbamolMethocarbamol TabletsAphena Pharma Solutions - Tennessee, LLCANDACurrent
80425-0020RobaxinMethocarbamolADVANCED RX PHARMACY OF TENNESSEE, LLCANDACurrent
80425-0020RobaxinMethocarbamolADVANCED RX PHARMACY OF TENNESSEE, LLCANDACurrent
80425-0020MethocarbamolMethocarbamolADVANCED RX PHARMACY OF TENNESSEE, LLCANDACurrent
80425-0020MethocarbamolMethocarbamolADVANCED RX PHARMACY OF TENNESSEE, LLCANDACurrent