Application 207402

Type
ANDA
Sponsor
MICRO LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDECAPSULE;ORALEQ 75MG BASENoNo
002CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDECAPSULE;ORALEQ 150MG BASENoNo
003CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDECAPSULE;ORALEQ 300MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207402-001CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-05
A207402-002CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2018-11-05
A207402-003CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2018-11-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A207402-001AB
A207402-002AB
A207402-003AB

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 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A207402-001CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-0584e616aacf4f…
2026-09-14 22:38:342026-08A207402-002CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2018-11-0584e616aacf4f…
2026-09-14 22:38:342026-08A207402-003CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2018-11-0584e616aacf4f…
2026-08-18 06:07:402026-07A207402-001CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-05caaa826d4ba7…
2026-08-18 06:07:402026-07A207402-002CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2018-11-05caaa826d4ba7…
2026-08-18 06:07:402026-07A207402-003CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2018-11-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207402-001CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207402-002CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2018-11-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207402-003CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2018-11-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207402-001CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207402-002CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2018-11-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207402-003CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2018-11-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A207402-001CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207402-002CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2018-11-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207402-003CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2018-11-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207402-001CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207402-002CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2018-11-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207402-003CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2018-11-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207402-001CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207402-002CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2018-11-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207402-003CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2018-11-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207402-001CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207402-002CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2018-11-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207402-003CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2018-11-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207402-001CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207402-002CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2018-11-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207402-003CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2018-11-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207402-001CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207402-002CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2018-11-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207402-003CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2018-11-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207402-001CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207402-002CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2018-11-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207402-003CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2018-11-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207402-001CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A207402-002CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2018-11-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A207402-003CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2018-11-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207402-001CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207402-002CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2018-11-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207402-003CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2018-11-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207402-001CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-05301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A207402-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A207402-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A207402-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A207402-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207402-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207402-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207402-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207402-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207402-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207402-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207402-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207402-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207402-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207402-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207402-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207402-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207402-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207402-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207402-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207402-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207402-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207402-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207402-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207402-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207402-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207402-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207402-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207402-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207402-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207402-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207402-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207402-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207402-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207402-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207402-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207402-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207402-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207402-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207402-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207402-001AB1301d65b070ca…

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 · 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.8e3c9cf6-ab39-4fb5-94e3-232880c477002026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.de7001d1-8b83-4f8b-8e50-c076910214562026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
ndc (product): 72789-180
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEBryant Ranch Prepack5f6a85c5-dca3-49b1-a029-3818a41d49bf2026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDESt. Mary's Medical Park Pharmacyafeb96ed-7c2e-72d3-e053-2995a90a4ed32026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.bde81d4b-ad21-cc09-e053-2995a90a8c012026-02-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.ba9bd5cd-036b-4b0c-e053-2a95a90a332e2026-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDERedPharm Drug, Inc.a2f6fa76-a114-4104-e053-2a95a90a9e0b2026-01-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDENorthwind Health Company, LLCf6f5c8b2-83a1-5362-e053-6394a90aaaad2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEBryant Ranch Prepackcd2ca915-5672-440d-a14e-b4d3b6a522f32025-09-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEDIRECT RXc3f35f80-e4ae-95f5-e053-2995a90a1b642025-07-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEQuality Care Products, LLC1d562ae9-5a9a-4fed-8cc7-3f30fb40f9572024-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEBryant Ranch Prepackbea7de4c-c077-4535-96a0-f6b319120b0b2024-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.b2bd8402-c887-5bfd-e053-2a95a90a15d92024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEAdvanced Rx of Tennessee, LLC1d760cb7-d166-6707-e063-6394a90a88502024-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.9e68cb17-73d9-8a00-e053-2995a90a517f2024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.9fe44bdd-eb59-4b55-e053-2995a90a31832024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEAvPAKb2a810f1-c009-e973-e053-2a95a90ad5b02024-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEA-S Medication Solutions07f5d841-9c58-4dd1-b0bc-e12553931c8e2023-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEA-S Medication Solutions18ef4551-4066-4765-90cb-285d7711cf612023-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEProficient Rx LPf7e51a42-bc9e-490f-b8d8-8765f0b5be462022-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402

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 · 90 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
72789-180CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-180CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-180CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-180CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-180CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-180CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-180CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-180CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-180CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-180CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent